Pain ManagementNCT07260396
Comparison of Sensory Block Coverage and Clinical Effectiveness of TAP and Rectus Sheath Blocks in Pfannenstiel Incisions
An observational study of Pain Management and Hysterectomy, run by Samsun University.
Trial summary
Hysterectomy is one of the most common major gynecologic surgeries performed for various indications, and hundreds of thousands of procedures are carried out annually, particularly in developed countries. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain Management, Hysterectomy
- What is being tested?
- Group Transversus Abdominis Plane Block and Group Rectus Sheath Block
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for total abdominal hysterectomy with a Pfannenstiel incision and receiving regional anesthesia as part of their perioperative analgesia management will be included in the study.
Who may be able to join
- ASA physical status I-II-III
- Patients scheduled for elective total abdominal hysterectomy under general anesthesia and who have received either a preoperative rectus sheath block or a transversus abdominis plane block
- Aged 18-70 years
- Patients who agree to participate in the study and provide written informed consent
Who cannot join
- Patients who refuse to participate
- Patients who have not received any regional anesthesia technique
- ASA physical status IV
- Patients in whom unilateral or bilateral sensory spread is not observed following the bilaterally applied regional anesthesia technique
- Patients who are uncooperative or have cognitive impairment or dementia
- Patients with psychiatric disorders such as depression, mania, or schizophrenia, or those using antipsychotic medications for more than 4 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Cutaneous Sensory Block Coverage of Surgical Incisions and Clinical Effectiveness of TAP and Rectus Sheath Blocks in Total Abdominal Hysterectomies Performed With a Pfannenstiel Incision: A Prospective Observational Study
Hysterectomy is one of the most common major gynecologic surgeries performed for various indications, and hundreds of thousands of procedures are carried out annually, particularly in developed countries. In total abdominal hysterectomies, the Pfannenstiel incision is frequently preferred due to its advantages in terms of aesthetics, functionality, and postoperative recovery. However, this incision can cause significant postoperative pain because of the extensive cutaneous innervation of the lower abdominal wall. This pain may delay early mobilization and negatively affect patient comfort and satisfaction.
As part of multimodal analgesia strategies, regional anesthesia techniques are widely used in such surgeries to reduce opioid consumption and enhance analgesic efficacy. In this context, the Transversus Abdominis Plane (TAP) block and the Rectus Sheath Block (RSB) are among the effective techniques targeting the anterior abdominal wall, and various studies have investigated their spread patterns and clinical outcomes. However, data on the extent to which these blocks provide cutaneous sensory coverage of the Pfannenstiel incision remain limited, and direct comparative mapping studies are scarce in the literature.
Read more
For patients undergoing hysterectomy, regional anesthesia techniques are commonly applied perioperatively either as a single technique or in combination for pain management, with TAP and RSB being the most frequently used modalities. In addition, patient-controlled analgesia (PCA) devices are routinely employed as a component of multimodal pain management in this population.
The aim of this study is to comparatively evaluate the cutaneous sensory block areas produced by the TAP and RSB regional anesthesia techniques, their rates of coverage of the Pfannenstiel incision, and their clinical effectiveness.
Read the detailed description
Inadequate pain control after hysterectomy is associated with prolonged hospital stay, delayed recovery, decreased quality of life, and reduced patient satisfaction. Therefore, multimodal analgesia strategies that provide high analgesic efficacy with a low side-effect profile are essential in these patients during the postoperative period. Effective postoperative analgesia may also reduce the risk of developing chronic pain after hysterectomy. Although opioids are often routinely used in the postoperative period, their widespread use may lead to adverse effects such as nausea and vomiting, constipation, pruritus, urinary retention, respiratory depression, and, in the long term, an increased risk of misuse.
In our clinic, regional anesthesia techniques under ultrasound guidance are routinely administered by experienced anesthesiologists-either as single techniques or in combination-for perioperative pain management in patients undergoing hysterectomy. In addition, patient-controlled analgesia (PCA) devices are used as part of multimodal pain management.
This study was designed as an observational study. It aims to comparatively evaluate the cutaneous sensory block areas produced by bilateral Transversus Abdominis Plane (TAP) block and bilateral Rectus Sheath Block (RSB) in patients undergoing elective total abdominal hysterectomy with a Pfannenstiel incision under general anesthesia, focusing on the extent to which these regional anesthesia techniques cover the Pfannenstiel incision and their clinical effectiveness.
Among the patients who receive either of these techniques, written informed consent will be obtained, and sensory anesthesia will be evaluated at the 45th minute using the pinprick test. The sensory borders identified during the assessment will be marked on the patient's abdomen, after which an acetate sheet will be placed over the abdomen to transfer the anatomical projection of these borders. Additionally, anterior abdominal reference landmarks specific to each patient (xiphoid process, costal margin, anterior axillary line, iliac crest, inguinal ligament, and symphysis pubis) will be marked on the acetate sheet. Before the surgery begins, the Pfannenstiel incision planned by the surgeon will be drawn on the patient and transferred onto the acetate sheet.
Each acetate template will then be digitized, and the percentage of Pfannenstiel incision coverage by the cutaneous sensory block area produced by the regional anesthesia technique will be calculated using ImageJ software. Furthermore, the percentage of the anterior abdominal wall covered by the bilaterally applied regional anesthesia technique will be calculated separately for each patient.
Postoperatively, patients' pain scores will be recorded at 1, 3, 6, 12, 18, and 24 hours using the Numerical Rating Scale (NRS), both at rest and during coughing. Total analgesic consumption from the PCA device will also be documented at the same time intervals. At the end of the 24th hour, all patients will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
- Conditions
- Pain Management, Hysterectomy
- Being tested
- Group Transversus Abdominis Plane Block, Group Rectus Sheath Block
- Keywords
- Regional Anesthesia, Postoperative Pain, Cutaneous Sensory Mapping
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Transversus Abdominis Plane BlockProcedure or surgery
Patients will receive a bilateral transversus abdominis plane block preoperatively under ultrasound guidance.
Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals.
Group Rectus Sheath BlockProcedure or surgery
Patients will receive a bilateral rectus sheath block preoperatively under ultrasound guidance.
Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| Group Transversus Abdominis Plane Block (TAPB) | Patients who received an ultrasound-guided bilateral Transversus Abdominis Plane Block during the preoperative period. Receives: Procedure: Group Transversus Abdominis Plane Block | |
| Group Rectus Sheath Block (RSB) | Patients who received an ultrasound-guided bilateral Rectus Sheath Block during the preoperative period. Receives: Procedure: Group Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the coverage rates of the Pfannenstiel incision by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.
Measured: 45 minutes after block application
Secondary outcomes (4)
Calculation of the coverage rates of the anterior abdomen by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.
Measured: 45 minutes after block application
Comparison of 24-hour morphine consumption between the two groups.
Measured: First 24 postoperative hours
Comparison of Numerical Rating Scale (NRS) scores between the two groups.
Measured: Postoperative 1, 3, 6, 12, 18, and 24. hours
Comparison of Quality of Recovery-15 (QoR-15) scores between the two groups.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevda Akdeniz, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260396
- Sponsor's protocol ID
- GOKAEK 2025/20/18
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aoyama Y, Sakura S, Abe S, Wada M, Saito Y. Analgesic effects and distribution of cutaneous sensory blockade of quadratus lumborum block type 2 and posterior transversus abdominis plane block: an observational comparative study. Korean J Anesthesiol. 2020 Aug;73(4):326-333. doi: 10.4097/kja.19404. Epub 2020 Jan 31.
PubMed 32008278Abuelghar WM, El-Bishry G, Emam LH. Caesarean deliveries by Pfannenstiel versus Joel-Cohen incision: A randomised controlled trial. J Turk Ger Gynecol Assoc. 2013 Dec 1;14(4):194-200. doi: 10.5152/jtgga.2013.75725. eCollection 2013.
PubMed 24592105Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
PubMed 37642285
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cutaneous Sensory Block Coverage of Surgical Incisions and Clinical Effectiveness of TAP and Rectus Sheath Blocks in Total Abdominal Hysterectomies Performed With a Pfannenstiel Incision: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07260396
- Acronym / sponsor ID
- GOKAEK 2025/20/18
- Conditions
- Pain Management, Hysterectomy
- Keywords
- Regional Anesthesia, Postoperative Pain, Cutaneous Sensory Mapping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Dec 2025 (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.
Hysterectomy is one of the most common major gynecologic surgeries performed for various indications, and hundreds of thousands of procedures are carried out annually, particularly in developed countries. In total abdominal hysterectomies, the Pfannenstiel incision is frequently preferred due to its advantages in terms of aesthetics, functionality, and postoperative recovery. However, this incision can cause significant postoperative pain because of the extensive cutaneous innervation of the lower abdominal wall. This pain may delay early mobilization and negatively affect patient comfort and satisfaction.
As part of multimodal analgesia strategies, regional anesthesia techniques are widely used in such surgeries to reduce opioid consumption and enhance analgesic efficacy. In this context, the Transversus Abdominis Plane (TAP) block and the Rectus Sheath Block (RSB) are among the effective techniques targeting the anterior abdominal wall, and various studies have investigated their spread patterns and clinical outcomes. However, data on the extent to which these blocks provide cutaneous sensory coverage of the Pfannenstiel incision remain limited, and direct comparative mapping studies are scarce in the literature.
For patients undergoing hysterectomy, regional anesthesia techniques are commonly applied perioperatively either as a single technique or in combination for pain management, with TAP and RSB being the most frequently used modalities. In addition, patient-controlled analgesia (PCA) devices are routinely employed as a component of multimodal pain management in this population.
The aim of this study is to comparatively evaluate the cutaneous sensory block areas produced by the TAP and RSB regional anesthesia techniques, their rates of coverage of the Pfannenstiel incision, and their clinical effectiveness.
Detailed description
Inadequate pain control after hysterectomy is associated with prolonged hospital stay, delayed recovery, decreased quality of life, and reduced patient satisfaction. Therefore, multimodal analgesia strategies that provide high analgesic efficacy with a low side-effect profile are essential in these patients during the postoperative period. Effective postoperative analgesia may also reduce the risk of developing chronic pain after hysterectomy. Although opioids are often routinely used in the postoperative period, their widespread use may lead to adverse effects such as nausea and vomiting, constipation, pruritus, urinary retention, respiratory depression, and, in the long term, an increased risk of misuse.
In our clinic, regional anesthesia techniques under ultrasound guidance are routinely administered by experienced anesthesiologists-either as single techniques or in combination-for perioperative pain management in patients undergoing hysterectomy. In addition, patient-controlled analgesia (PCA) devices are used as part of multimodal pain management.
This study was designed as an observational study. It aims to comparatively evaluate the cutaneous sensory block areas produced by bilateral Transversus Abdominis Plane (TAP) block and bilateral Rectus Sheath Block (RSB) in patients undergoing elective total abdominal hysterectomy with a Pfannenstiel incision under general anesthesia, focusing on the extent to which these regional anesthesia techniques cover the Pfannenstiel incision and their clinical effectiveness.
Among the patients who receive either of these techniques, written informed consent will be obtained, and sensory anesthesia will be evaluated at the 45th minute using the pinprick test. The sensory borders identified during the assessment will be marked on the patient's abdomen, after which an acetate sheet will be placed over the abdomen to transfer the anatomical projection of these borders. Additionally, anterior abdominal reference landmarks specific to each patient (xiphoid process, costal margin, anterior axillary line, iliac crest, inguinal ligament, and symphysis pubis) will be marked on the acetate sheet. Before the surgery begins, the Pfannenstiel incision planned by the surgeon will be drawn on the patient and transferred onto the acetate sheet.
Each acetate template will then be digitized, and the percentage of Pfannenstiel incision coverage by the cutaneous sensory block area produced by the regional anesthesia technique will be calculated using ImageJ software. Furthermore, the percentage of the anterior abdominal wall covered by the bilaterally applied regional anesthesia technique will be calculated separately for each patient.
Postoperatively, patients' pain scores will be recorded at 1, 3, 6, 12, 18, and 24 hours using the Numerical Rating Scale (NRS), both at rest and during coughing. Total analgesic consumption from the PCA device will also be documented at the same time intervals. At the end of the 24th hour, all patients will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Transversus Abdominis Plane Block (TAPB) | – | Procedure: Group Transversus Abdominis Plane BlockPatients who received an ultrasound-guided bilateral Transversus Abdominis Plane Block during the preoperative period. |
| Group Rectus Sheath Block (RSB) | – | Procedure: Group Rectus Sheath BlockPatients who received an ultrasound-guided bilateral Rectus Sheath Block during the preoperative period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for total abdominal hysterectomy with a Pfannenstiel incision and receiving regional anesthesia as part of their perioperative analgesia management will be included in the study.
Key inclusion criteria (4 listed)
- ASA physical status I-II-III
- Patients scheduled for elective total abdominal hysterectomy under general anesthesia and who have received either a preoperative rectus sheath block or a transversus abdominis plane block
- Aged 18-70 years
- Patients who agree to participate in the study and provide written informed consent
Key exclusion criteria (6 listed)
- Patients who refuse to participate
- Patients who have not received any regional anesthesia technique
- ASA physical status IV
- Patients in whom unilateral or bilateral sensory spread is not observed following the bilaterally applied regional anesthesia technique
- Patients who are uncooperative or have cognitive impairment or dementia
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 |
|---|---|---|
| Group Transversus Abdominis Plane BlockPatients will receive a bilateral transversus abdominis plane block preoperatively under ultrasound guidance. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals. | Procedure or surgery | Group Transversus Abdominis Plane Block (TAPB) |
| Group Rectus Sheath BlockPatients will receive a bilateral rectus sheath block preoperatively under ultrasound guidance. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points. Additionally, patients will be provided with a PCA device, and morphine consumption as well as NRS pain scores will be monitored at regular intervals. | Procedure or surgery | Group Rectus Sheath Block (RSB) |
Primary outcome
Calculation of the coverage rates of the Pfannenstiel incision by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.
Time frame: 45 minutes after block application
4 secondary outcomes
Calculation of the coverage rates of the anterior abdomen by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block.
Time frame: 45 minutes after block application
Comparison of 24-hour morphine consumption between the two groups.
Time frame: First 24 postoperative hours
Comparison of Numerical Rating Scale (NRS) scores between the two groups.
Time frame: Postoperative 1, 3, 6, 12, 18, and 24. hours
Comparison of Quality of Recovery-15 (QoR-15) scores between the two groups.
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 32008278Aoyama Y, Sakura S, Abe S, Wada M, Saito Y. Analgesic effects and distribution of cutaneous sensory blockade of quadratus lumborum block type 2 and posterior transversus abdominis plane block: an observational comparative study. Korean J Anesthesiol. 2020 Aug;73(4):326-333. doi: 10.4097/kja.19404. Epub 2020 Jan 31.
- Background: PubMed 24592105Abuelghar WM, El-Bishry G, Emam LH. Caesarean deliveries by Pfannenstiel versus Joel-Cohen incision: A randomised controlled trial. J Turk Ger Gynecol Assoc. 2013 Dec 1;14(4):194-200. doi: 10.5152/jtgga.2013.75725. eCollection 2013.
- Background: PubMed 37642285Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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.
Sevda Akdeniz study director
Samsun University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Hysterectomy, run by Samsun University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Yilmaz, M.D. (905458341318, yildizbusra.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the coverage rates of the Pfannenstiel incision by the cutaneous sensory block areas generated by the transversus abdominis plane block and the rectus sheath block. (time frame: 45 minutes after block application). 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 NCT07260396, which also lists 3 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 3 Dec 2025.