Postoperative PainNCT05840406
Effect of a Transversus Abdominis Plane Block on Wound Healing, Stress, and Immune Response After a Cesarean Delivery
A study testing Postoperative pain management with acetaminophen, Bilateral TAP Block with levobupivacaine and Bilateral TAP Block with levobupivacaine and dexmedetomidine in people with Postoperative Pain and Cesarean Section, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Cesarean Section, Wound Heal
- What is being tested?
- Postoperative pain management with acetaminophen, Bilateral TAP Block with levobupivacaine and Bilateral TAP Block with levobupivacaine and dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCroatia
- Study dates
- 3 Sep 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for the elective cesarean section through Pfannenstiel incision under spinal anesthesia
- Age >18
- American Society of Anesthesiologists (ASA) physical status II
- Body mass index < 40 mg/kg²
- >35 gestational weeks
Who cannot join
- participant's refusal to participate in the study
- ASA physical status >II
- emergency cesarean section
- twin or triplets pregnancy
- history of allergy to the local anesthetic or any other drug used in this study (dexmedetomidine, acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs)
- contraindications for spinal anesthesia or TAP block
Show all 11Show fewer
- Drop out from the study:
- the change in anesthetic technique from spinal to the general anesthesia
- the need for the blood transfusion
- acute mastitis, puerperal endometritis, and/or wound infection developed in the first 72 hours postoperatively
- failed TAP block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery
The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response.
Random allocation of participants in 3 groups: group SA (standard analgesia), group L (TAP block with levobupivacaine), and group D (TAP block with levobupivacaine + dexmedetomidine). All participants will undergo elective cesarean section through Pfannestiel incision under spinal anesthesia. They will receive standard postoperative pain management with acetaminophen, nonsteroidal anti-inflammatory drugs, and tramadol. Groups L and D will additionally receive bilateral ultrasound-guided TAP block with 20 ml 0,25% levobupivacaine or with 20 ml 0,25% levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine. TAP block will be performed in the theatre immediately after the cesarean delivery.
Venous blood samples will be collected before the surgery and on the third postoperative day. Complete blood count and serum cortisol levels will be measured. REEDA scale will be used for assessing wound healing.
Read the detailed description
Introduction. Cesarean section is one of the world's most frequently performed surgical procedures. It is often accompanied by severe postoperative pain that leads to a complex immune and stress response in the body. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are reliable and readily available markers of immune response to various infectious and non-infectious stimuli. Elevated NLR and PLR values are predictive in the early detection of wound infection after cesarean section. Wound healing involves three stages: inflammation, proliferation, and remodeling. REEDA scale is a valid tool for assessing obstetric wound healing. Many factors can affect the wound-healing process. Consistent overlap between pain-related dysregulation of neuroendocrine and immune function and the aspects of the neuroendocrine and immune function shown to be critical in wound healing suggests that pain may play a role in delayed wound healing. Therefore, it is reasonable to assume that better postoperative analgesia could positively affect wound healing. According to previous research, the transversus abdominis plane (TAP) block significantly reduces pain and cortisol, epinephrine, and norepinephrine levels after cesarean section. The addition of dexmedetomidine to the local anesthetic in the TAP block has a more pronounced analgesic effect and prolongs the duration of analgesia. The investigators have found only one study that demonstrates that adding a TAP block to standard analgesia positively affects wound healing after cesarean delivery. In the literature search, investigators did not find any clinical study that has been carried out to see the influence of the addition of dexmedetomidine in TAP block on wound healing, stress response, and immune response after cesarean delivery.
We hypothesize that the use of bilateral transversus abdominis plane block after cesarean delivery will lead to lower values of the REEDA scale and attenuated stress and immune response of the patient compared to standard analgesia, where the addition of dexmedetomidine to levobupivacaine will have a more pronounced effect compared to TAP block with levobupivacaine.
Patients and methods: This prospective, randomized study will be conducted in the Department of Anesthesiology, Intensive Care Medicine and Pain Management and the Department of Gynecology and Obstetrics in the Sestre Milosrdnice University Hospital Center. A total of 120 participants will be included in the study.
The group size was obtained by power analysis. For each variable, the sample size required for cross-comparisons of the arithmetic means of the three groups was calculated using a two-tailed t-test with the power of the test β = 85%, and the level of statistical significance for each test, α = 1.667%. Standard deviations and expected differences in the arithmetic means of the examined groups were taken from the published literature. (2:24-26). The largest estimated sample size for the investigated variables is 35 subjects per group.
After the written and signed approval of the patients, they will be randomly allocated to either a control group that receives the standard postoperative analgesia (group SA) or groups that further receive the TAP block with levobupivacaine (group L), with and without the addition of dexmedetomidine (group D). All the participants will undergo elective cesarean delivery under spinal anesthesia. The classic cesarean section technique described by Pfannenstiel and Kerr technique will be performed on all the participants. The spinal anesthesia will be performed with an atraumatic spinal needle by applying height- and weight-adjusted dose of hyperbaric bupivacaine and 25 μg fentanyl intrathecally. All the participants will receive standard postoperative analgesia according to the Acute Pain Service Sestre Milosrdnice University Hospital Center (acetaminophen, tramadol, and nonsteroidal anti-inflammatory drugs). Group L and group D will additionally receive a bilateral TAP block. 20 ml of 0,25 % levobupivacaine will be administered on each side to the participants in group L and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered on each side to the participants in group D. TAP block will be performed under sterile conditions. The high-frequency linear probe will be placed transversally in the medial axillary line, and the three layers of abdominal muscles will be visualized. A 22G echogenic needle for peripheral nerve blocks will be used to inject the mixed solution in the plane between the transversus abdominis and internal oblique muscles.
Venous blood samples will be collected the day before the surgery, at 7 a.m. on the day of surgery, and at 7 a.m. on the third postoperative day. Complete blood count and serum cortisol levels will be measured. An independent observer will assess wound healing using the standardized Redness, edema, ecchymosis, discharge, and approximation (REEDA) scale 72 hours after the cesarean delivery.
Statistical analysis: The collected data for each variable will be summarized and analyzed depending on the normality of the distribution, which will be tested with the Shapiro-Wilk test. In the case of a normal distribution, the measured values will be summarized by the arithmetic mean and standard deviation. The effects of the treatment will be tested with a mixed model in which the measured value will be the dependent variable. In case of deviation from the normal distribution, the measured values will be summarized by the meridian and the first and third quartiles. Before the analysis with the mixed model they will be transformed by the inverse transformation of the ranks into the standard normal function. The calculated p-values will be considered statistically significant if they are less than 5%.
- Conditions
- Postoperative Pain, Cesarean Section, Wound Heal
- Being tested
- Postoperative pain management with acetaminophen, Bilateral TAP Block with levobupivacaine, Bilateral TAP Block with levobupivacaine and dexmedetomidine, Postoperative pain management with tramadol, Postoperative pain management with ketoprofen
- Keywords
- Cesarean section, Wound healing, Nerve block, Cortisol, Immune response
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative pain management with acetaminophenDrug
During the 24 hours postoperatively, participants will receive 1 g acetaminophen intravenously (i.v.) three times a day. On the second and third postoperative days, participants will receive 1g acetaminophen per os three times a day.
Bilateral TAP Block with levobupivacaineProcedure or surgery
Ultrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine will be administered to the participant on each side.
Bilateral TAP Block with levobupivacaine and dexmedetomidineProcedure or surgery
Ultrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered to the participant on each side.
Postoperative pain management with tramadolDrug
During the 24 hours postoperatively, participants will receive 500 mg tramadol + 500 ml 0,9% NaCl i.v. continuously 30ml/h.
Postoperative pain management with ketoprofenDrug
During the 24 hours postoperatively, participants will receive 100 mg ketoprofen + 100 ml of 0,9% NaCl i.v. twice a day. The first dose will be administered in the theatre at the end of the surgical procedure.
Postoperative pain management with ibuprofenDrug
On the second and third postoperative days, participants will receive 600 mg ibuprofen per os three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Group SA | Active comparator | No TAP block applied. Receives: Drug: Postoperative pain management with acetaminophen; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen |
| Group L | Experimental | Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side. Receives: Drug: Postoperative pain management with acetaminophen; Procedure: Bilateral TAP Block with levobupivacaine; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen |
| Group D | Experimental | Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side. Receives: Drug: Postoperative pain management with acetaminophen; Procedure: Bilateral TAP Block with levobupivacaine and dexmedetomidine; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing will be assessed 72 hours after cesarean delivery using a standardized REEDA scale. REEDA includes five factors associated with the healing of an incision: redness, edema, ecchymosis, discharge, and approximation of the two edges of the wound, each receiving a score between 0-3, with a higher score indicating a greater level of tissue trauma and less healed wound compared to lower scores.
Measured: 72 hours after the surgery
Measure the stress response (serum cortisol)
Venous blood samples will be collected at 7 a.m. on the day of surgery and at 7 a.m. on the 3rd postoperative day. Serum cortisol levels will be measured by using electrochemiluminescence immunoassay (ECLIA).
Measured: up to 72 hours
Measure immune response (neutrophil to lymphocyte ratio)
The neutrophil to lymphocyte ratio will be calculated as a simple ratio between absolute neutrophil and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.
Measured: up to 72 hours
Measure immune response (platelet to lymphocyte ratio)
The platelet to lymphocyte ratio will be calculated as a simple ratio between absolute platelet and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.
Measured: up to 72 hours
Secondary outcomes (2)
Postoperative pain score
A Numeric Rating Scale will measure pain at rest and on movement. The numeric Rating Scale will be from 0 to 10, where 0 is no pain, and 10 is the most severe pain. Pain will be assessed for each participant at 4, 8, 12, 18, 24, and 72 hours after surgery.
Measured: 4, 8, 12, 18, 24, and 72 hours after surgery
Quality of recovery
The quality of recovery will be measured by the Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool 24 hours after the surgery. ObsQoR-10© is a 10-item, participant-reported scoring tool that assesses postpartum recovery. It consists of 2 parts. In the first part, the subject self-evaluates the intensity of the four listed symptoms on a vertical visual-analog scale. The end points are marked with 0 - no symptoms and 10 - the worst possible intensity of symptoms. The second part consists of 6 questions assessing recovery in the last 24 hours, which the respondent also evaluates with a vertical visual-analog scale where the end points are marked with 0 - never and 10 - always. Possible scores range from 0 to 100, with a higher score indicating better postpartum recovery.
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start3 Sep 2024
- Primary completion17 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single-blind randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirta Ciglar, MD, University Hospital Sestre Milosrdnice
- Investigators
- Mirta Ciglar, MD, Principal investigator, University Hospital Center Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840406
- Sponsor's protocol ID
- 003-06/22-03/007
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavand'homme P. Postoperative cesarean pain: real but is it preventable? Curr Opin Anaesthesiol. 2018 Jun;31(3):262-267. doi: 10.1097/ACO.0000000000000585.
PubMed 29521684Ernawati E, Amirah A, Sumartono C, Aditiawarman A. Comparison of Post-Caesarean Section Wound Healing Methods Based on Reeda Scale and Platelet Lymphocyte Ratio. Syst Rev Pharm. 2020;11(7):5. doi:10.31838/srp.2020.7.49
Rotem R, Erenberg M, Rottenstreich M, Segal D, Yohay Z, Idan I, Yohay D, Weintraub AY. Early prediction of post cesarean section infection using simple hematological biomarkers: A case control study. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:84-88. doi: 10.1016/j.ejogrb.2019.12.009. Epub 2019 Dec 23.
PubMed 31884150Hughes O, MacQuhae F, Rakosi A, Herskovitz I, Kirsner RS. Stress and wound healing. U: França K, Jafferany M, ur. Stress and skin disorders: Basic and clinical aspects. Cham: Springer; 2017. P. 185-207.
Childs C, Sandy-Hodgetts K, Broad C, Cooper R, Manresa M, Verdu-Soriano J. Risk, Prevention and Management of Complications After Vaginal and Caesarean Section Birth. J Wound Care. 2020 Nov 1;29(Sup11a):S1-S48. doi: 10.12968/jowc.2020.29.Sup11a.S1. No abstract available.
PubMed 33170077Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
PubMed 21296242Liu R, Qin H, Wang M, Li K, Zhao G. Transversus abdominis plane block with general anesthesia blunts the perioperative stress response in patients undergoing radical gastrectomy. BMC Anesthesiol. 2019 Nov 7;19(1):205. doi: 10.1186/s12871-019-0861-0.
PubMed 31699052Varshney A, Prabhu M, Periyadka B, Nanjundegowda DC, Rao A. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):161-164. doi: 10.4103/joacp.JOACP_372_17.
PubMed 31303702Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.
PubMed 30475260Surhonne N, Hebri C, Kannan S, Duggappa DR, Rs RR, Mapari CG. The effect of anesthetic techniques on neutrophil to lymphocyte ratio in patients undergoing infraumbilical surgeries. Korean J Anesthesiol. 2019 Oct;72(5):458-465. doi: 10.4097/kja.d.19.00022. Epub 2019 May 17.
PubMed 31096728Kiriakopoulos N, Grigoriadis S, Maziotis E, Philippou A, Rapani A, Giannelou P, Tsioulou P, Sfakianoudis K, Kontogeorgi A, Bakas P, Mastorakos G, Koutsilieris M, Simopoulou M. Investigating Stress Response during Vaginal Delivery and Elective Cesarean Section through Assessment of Levels of Cortisol, Interleukin 6 (IL-6), Growth Hormone (GH) and Insulin-Like Growth Factor 1 (IGF-1). J Clin Med. 2019 Jul 27;8(8):1112. doi: 10.3390/jcm8081112.
PubMed 31357604McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
PubMed 18165577Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17.
PubMed 33345919
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05840406
- Acronym / sponsor ID
- 003-06/22-03/007
- Conditions
- Postoperative Pain, Cesarean Section, Wound Heal
- Keywords
- Cesarean section, Wound healing, Nerve block, Cortisol, Immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response.
Random allocation of participants in 3 groups: group SA (standard analgesia), group L (TAP block with levobupivacaine), and group D (TAP block with levobupivacaine + dexmedetomidine). All participants will undergo elective cesarean section through Pfannestiel incision under spinal anesthesia. They will receive standard postoperative pain management with acetaminophen, nonsteroidal anti-inflammatory drugs, and tramadol. Groups L and D will additionally receive bilateral ultrasound-guided TAP block with 20 ml 0,25% levobupivacaine or with 20 ml 0,25% levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine. TAP block will be performed in the theatre immediately after the cesarean delivery.
Venous blood samples will be collected before the surgery and on the third postoperative day. Complete blood count and serum cortisol levels will be measured. REEDA scale will be used for assessing wound healing.
Detailed description
Introduction. Cesarean section is one of the world's most frequently performed surgical procedures. It is often accompanied by severe postoperative pain that leads to a complex immune and stress response in the body. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are reliable and readily available markers of immune response to various infectious and non-infectious stimuli. Elevated NLR and PLR values are predictive in the early detection of wound infection after cesarean section. Wound healing involves three stages: inflammation, proliferation, and remodeling. REEDA scale is a valid tool for assessing obstetric wound healing. Many factors can affect the wound-healing process. Consistent overlap between pain-related dysregulation of neuroendocrine and immune function and the aspects of the neuroendocrine and immune function shown to be critical in wound healing suggests that pain may play a role in delayed wound healing. Therefore, it is reasonable to assume that better postoperative analgesia could positively affect wound healing. According to previous research, the transversus abdominis plane (TAP) block significantly reduces pain and cortisol, epinephrine, and norepinephrine levels after cesarean section. The addition of dexmedetomidine to the local anesthetic in the TAP block has a more pronounced analgesic effect and prolongs the duration of analgesia. The investigators have found only one study that demonstrates that adding a TAP block to standard analgesia positively affects wound healing after cesarean delivery. In the literature search, investigators did not find any clinical study that has been carried out to see the influence of the addition of dexmedetomidine in TAP block on wound healing, stress response, and immune response after cesarean delivery.
We hypothesize that the use of bilateral transversus abdominis plane block after cesarean delivery will lead to lower values of the REEDA scale and attenuated stress and immune response of the patient compared to standard analgesia, where the addition of dexmedetomidine to levobupivacaine will have a more pronounced effect compared to TAP block with levobupivacaine.
Patients and methods: This prospective, randomized study will be conducted in the Department of Anesthesiology, Intensive Care Medicine and Pain Management and the Department of Gynecology and Obstetrics in the Sestre Milosrdnice University Hospital Center. A total of 120 participants will be included in the study.
The group size was obtained by power analysis. For each variable, the sample size required for cross-comparisons of the arithmetic means of the three groups was calculated using a two-tailed t-test with the power of the test β = 85%, and the level of statistical significance for each test, α = 1.667%. Standard deviations and expected differences in the arithmetic means of the examined groups were taken from the published literature. (2:24-26). The largest estimated sample size for the investigated variables is 35 subjects per group.
After the written and signed approval of the patients, they will be randomly allocated to either a control group that receives the standard postoperative analgesia (group SA) or groups that further receive the TAP block with levobupivacaine (group L), with and without the addition of dexmedetomidine (group D). All the participants will undergo elective cesarean delivery under spinal anesthesia. The classic cesarean section technique described by Pfannenstiel and Kerr technique will be performed on all the participants. The spinal anesthesia will be performed with an atraumatic spinal needle by applying height- and weight-adjusted dose of hyperbaric bupivacaine and 25 μg fentanyl intrathecally. All the participants will receive standard postoperative analgesia according to the Acute Pain Service Sestre Milosrdnice University Hospital Center (acetaminophen, tramadol, and nonsteroidal anti-inflammatory drugs). Group L and group D will additionally receive a bilateral TAP block. 20 ml of 0,25 % levobupivacaine will be administered on each side to the participants in group L and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered on each side to the participants in group D. TAP block will be performed under sterile conditions. The high-frequency linear probe will be placed transversally in the medial axillary line, and the three layers of abdominal muscles will be visualized. A 22G echogenic needle for peripheral nerve blocks will be used to inject the mixed solution in the plane between the transversus abdominis and internal oblique muscles.
Venous blood samples will be collected the day before the surgery, at 7 a.m. on the day of surgery, and at 7 a.m. on the third postoperative day. Complete blood count and serum cortisol levels will be measured. An independent observer will assess wound healing using the standardized Redness, edema, ecchymosis, discharge, and approximation (REEDA) scale 72 hours after the cesarean delivery.
Statistical analysis: The collected data for each variable will be summarized and analyzed depending on the normality of the distribution, which will be tested with the Shapiro-Wilk test. In the case of a normal distribution, the measured values will be summarized by the arithmetic mean and standard deviation. The effects of the treatment will be tested with a mixed model in which the measured value will be the dependent variable. In case of deviation from the normal distribution, the measured values will be summarized by the meridian and the first and third quartiles. Before the analysis with the mixed model they will be transformed by the inverse transformation of the ranks into the standard normal function. The calculated p-values will be considered statistically significant if they are less than 5%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective single-blind randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Group SA | Active comparator | Drug: Postoperative pain management with acetaminophen, Drug: Postoperative pain management with tramadol, Drug: Postoperative pain management with ketoprofen, Drug: Postoperative pain management with ibuprofenNo TAP block applied. |
| Group L | Experimental | Drug: Postoperative pain management with acetaminophen, Procedure: Bilateral TAP Block with levobupivacaine, Drug: Postoperative pain management with tramadol, Drug: Postoperative pain management with ketoprofen, Drug: Postoperative pain management with ibuprofenUltrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side. |
| Group D | Experimental | Drug: Postoperative pain management with acetaminophen, Procedure: Bilateral TAP Block with levobupivacaine and dexmedetomidine, Drug: Postoperative pain management with tramadol, Drug: Postoperative pain management with ketoprofen, Drug: Postoperative pain management with ibuprofenUltrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for the elective cesarean section through Pfannenstiel incision under spinal anesthesia
- Age >18
- American Society of Anesthesiologists (ASA) physical status II
- Body mass index < 40 mg/kg²
- >35 gestational weeks
Key exclusion criteria (11 listed)
- participant's refusal to participate in the study
- ASA physical status >II
- emergency cesarean section
- twin or triplets pregnancy
- history of allergy to the local anesthetic or any other drug used in this study (dexmedetomidine, acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pain management with acetaminophenDuring the 24 hours postoperatively, participants will receive 1 g acetaminophen intravenously (i.v.) three times a day. On the second and third postoperative days, participants will receive 1g acetaminophen per os three times a day. | Drug | Group D, Group L, Group SA |
| Bilateral TAP Block with levobupivacaineUltrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine will be administered to the participant on each side. | Procedure or surgery | Group L |
| Bilateral TAP Block with levobupivacaine and dexmedetomidineUltrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered to the participant on each side. | Procedure or surgery | Group D |
| Postoperative pain management with tramadolDuring the 24 hours postoperatively, participants will receive 500 mg tramadol + 500 ml 0,9% NaCl i.v. continuously 30ml/h. | Drug | Group D, Group L, Group SA |
| Postoperative pain management with ketoprofenDuring the 24 hours postoperatively, participants will receive 100 mg ketoprofen + 100 ml of 0,9% NaCl i.v. twice a day. The first dose will be administered in the theatre at the end of the surgical procedure. | Drug | Group D, Group L, Group SA |
| Postoperative pain management with ibuprofenOn the second and third postoperative days, participants will receive 600 mg ibuprofen per os three times a day. | Drug | Group D, Group L, Group SA |
Primary outcome
Wound healing
Time frame: 72 hours after the surgery
Wound healing will be assessed 72 hours after cesarean delivery using a standardized REEDA scale. REEDA includes five factors associated with the healing of an incision: redness, edema, ecchymosis, discharge, and approximation of the two edges of the wound, each receiving a score between 0-3, with a higher score indicating a greater level of tissue trauma and less healed wound compared to lower scores.
Measure the stress response (serum cortisol)
Time frame: up to 72 hours
Venous blood samples will be collected at 7 a.m. on the day of surgery and at 7 a.m. on the 3rd postoperative day. Serum cortisol levels will be measured by using electrochemiluminescence immunoassay (ECLIA).
Measure immune response (neutrophil to lymphocyte ratio)
Time frame: up to 72 hours
The neutrophil to lymphocyte ratio will be calculated as a simple ratio between absolute neutrophil and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.
Measure immune response (platelet to lymphocyte ratio)
Time frame: up to 72 hours
The platelet to lymphocyte ratio will be calculated as a simple ratio between absolute platelet and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.
2 secondary outcomes
Postoperative pain score
Time frame: 4, 8, 12, 18, 24, and 72 hours after surgery
Quality of recovery
Time frame: 24 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 29521684Lavand'homme P. Postoperative cesarean pain: real but is it preventable? Curr Opin Anaesthesiol. 2018 Jun;31(3):262-267. doi: 10.1097/ACO.0000000000000585.
- BackgroundErnawati E, Amirah A, Sumartono C, Aditiawarman A. Comparison of Post-Caesarean Section Wound Healing Methods Based on Reeda Scale and Platelet Lymphocyte Ratio. Syst Rev Pharm. 2020;11(7):5. doi:10.31838/srp.2020.7.49
- Background: PubMed 31884150Rotem R, Erenberg M, Rottenstreich M, Segal D, Yohay Z, Idan I, Yohay D, Weintraub AY. Early prediction of post cesarean section infection using simple hematological biomarkers: A case control study. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:84-88. doi: 10.1016/j.ejogrb.2019.12.009. Epub 2019 Dec 23.
- BackgroundHughes O, MacQuhae F, Rakosi A, Herskovitz I, Kirsner RS. Stress and wound healing. U: França K, Jafferany M, ur. Stress and skin disorders: Basic and clinical aspects. Cham: Springer; 2017. P. 185-207.
- Background: PubMed 33170077Childs C, Sandy-Hodgetts K, Broad C, Cooper R, Manresa M, Verdu-Soriano J. Risk, Prevention and Management of Complications After Vaginal and Caesarean Section Birth. J Wound Care. 2020 Nov 1;29(Sup11a):S1-S48. doi: 10.12968/jowc.2020.29.Sup11a.S1. No abstract available.
- Background: PubMed 21296242Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Background: PubMed 31699052Liu R, Qin H, Wang M, Li K, Zhao G. Transversus abdominis plane block with general anesthesia blunts the perioperative stress response in patients undergoing radical gastrectomy. BMC Anesthesiol. 2019 Nov 7;19(1):205. doi: 10.1186/s12871-019-0861-0.
- Background: PubMed 31303702Varshney A, Prabhu M, Periyadka B, Nanjundegowda DC, Rao A. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):161-164. doi: 10.4103/joacp.JOACP_372_17.
- Background: PubMed 30475260Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.
- Background: PubMed 31096728Surhonne N, Hebri C, Kannan S, Duggappa DR, Rs RR, Mapari CG. The effect of anesthetic techniques on neutrophil to lymphocyte ratio in patients undergoing infraumbilical surgeries. Korean J Anesthesiol. 2019 Oct;72(5):458-465. doi: 10.4097/kja.d.19.00022. Epub 2019 May 17.
- Background: PubMed 31357604Kiriakopoulos N, Grigoriadis S, Maziotis E, Philippou A, Rapani A, Giannelou P, Tsioulou P, Sfakianoudis K, Kontogeorgi A, Bakas P, Mastorakos G, Koutsilieris M, Simopoulou M. Investigating Stress Response during Vaginal Delivery and Elective Cesarean Section through Assessment of Levels of Cortisol, Interleukin 6 (IL-6), Growth Hormone (GH) and Insulin-Like Growth Factor 1 (IGF-1). J Clin Med. 2019 Jul 27;8(8):1112. doi: 10.3390/jcm8081112.
- Background: PubMed 18165577McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirta Ciglar, MD principal investigator
University Hospital Center Sestre Milosrdnice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative pain management with acetaminophen, Bilateral TAP Block with levobupivacaine and Bilateral TAP Block with levobupivacaine and dexmedetomidine in people with Postoperative Pain and Cesarean Section, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 72 hours after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840406, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.