Laparoscopic Inguinal Hernia RepairNCT06753240
The Effects of Abdominal Plane Blocks on Postoperative Quality of Recovery
An observational study of Laparoscopic Inguinal Hernia Repair and Quality of Recovery (QoR-15), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In laparoscopic inguinal hernia surgeries, although the effects of classical transversus abdominis plane (TAP) and Modified thoracoabdominal nerve block through perichondrial approach (m-TAPA) blocks on perioperative pain control and opioid consumption have been evaluated in various studies using classical scaling… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Inguinal Hernia Repair, Quality of Recovery (QoR-15), Postoperative Analgesia
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 3 Mar 2025
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions.
Who may be able to join
- Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions, by the General Surgery clinic between January 10, 2024 and October 17, 2024
- Aged between 18-65 years, with a Body Mass Index (BMI) < 35 kg/m²,
- Having an American Society of Anesthesiologists (ASA) physical risk score of I-III,
- Patients who have given informed consent.
Who cannot join
- Patients who refuse to participate in the study
- Emergency surgeries
- Patients who will undergo recurrent or bilateral surgery
- Patients with a BMI ≥ 35 kg/m²
- Presence of local infection or hematoma at the application site
- Presence of coagulopathy
Show all 11Show fewer
- History of known local anesthetic allergy or toxicity
- Patients with a history of hematological, renal, or hepatic diseases, or advanced respiratory or cardiac failure
- Patients with difficulty in cooperation, Alzheimer's, dementia, or psychiatric and neurological diseases
- Patients with a history of chronic analgesic use, chronic alcohol use, or substance addiction
- Patients who do not speak Turkish or have a language barrier
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752
About this study
Official title: The Effects of Ultrasound-Guided Abdominal Plane Blocks on Postoperative Pain and Quality of Recovery in Laparoscopic Inguinal Hernia Repair
In laparoscopic inguinal hernia surgeries, although the effects of classical transversus abdominis plane (TAP) and Modified thoracoabdominal nerve block through perichondrial approach (m-TAPA) blocks on perioperative pain control and opioid consumption have been evaluated in various studies using classical scaling methods, their impact on postoperative recovery quality remains an area open for further research. In this observational study, the investigator's primary goal is to evaluate the effects of lateral approach TAP and m-TAPA blocks, which are routinely used for postoperative analgesia, on postoperative pain and recovery quality in patients undergoing laparoscopic inguinal hernia surgery, using the QoR-15 scale. The investigator's secondary goal is to contribute to identifying the standard analgesia method that will reduce postoperative opioid use, nausea, and vomiting, and improve recovery quality.
Read the detailed description
Laparoscopic surgery is widely used in the repair of inguinal hernias, but it can cause moderate to severe postoperative pain. Perioperative pain management is essential for ensuring early mobilization of patients, reducing postoperative side effects and hospital stay durations, improving patient satisfaction, and preventing the development of chronic pain after surgery. The quality of postoperative recovery is influenced by various factors, such as the patient's preoperative characteristics, the type of surgery, the level of postoperative pain, and analgesic methods. In recent years, alongside traditional scales measuring classical parameters in evaluating postoperative recovery quality, new measurement tools focusing on patient satisfaction have been developed. One of these tools is the Quality of Recovery-15 (QoR-15) scale, which has been recommended by the European Society of Anaesthesiology for use in clinical studies investigating postoperative patient comfort and pain levels. This scale includes 15 questions across five different areas evaluating postoperative recovery from various perspectives: pain, physical comfort, physical independence, psychological support, and emotional state. The result is a score between 0 and 150, with higher scores indicating better recovery quality.
Ultrasound (USG)-guided abdominal plane blocks are an important part of multimodal analgesia due to their ease of application, ability to provide long-lasting postoperative analgesia, and potential to reduce opioid consumption. Various regional anesthesia techniques can be used for pain control following laparoscopic inguinal hernia repair surgeries (TransAbdominal Pre-Peritoneal approach-TAPP). Some of these techniques include the Transversus Abdominis Plane (TAP) block and the Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block. The TAP block is performed in the neurofascial plane between the internal oblique and transversus abdominis muscles, creating a dermatomal sensory block at the T6-L1 levels. It can be applied laterally, subcostally, or posteriorly. The Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block is used more recently in upper and lower abdominal surgeries to provide effective analgesia due to its wider dermatomal coverage. The m-TAPA block is performed under ultrasound guidance by injecting a local anesthetic between the costal cartilage and the transversus abdominis muscle, providing abdominal analgesia from T4-L1 along the anterior and lateral abdominal wall. Both TAP and m-TAPA blocks are regional analgesia techniques commonly applied in our daily practice after abdominal surgeries. The choice of regional anesthesia technique is determined based on the surgical region, type of surgery, and the experience of the anesthesia team.
This study includes 60 patients aged 18-65 years, classified in the American Society of Anesthesiologists (ASA) physical risk class I-III, who are scheduled to undergo elective laparoscopic inguinal hernia repair surgery under general anesthesia at the General Surgery Department of Fatih Sultan Mehmet Training and Research Hospital.Participants who are planning to receive M-TAPA block defines as Group M-TAPA, and those who receive lateral TAP block defines as Group TAP, with 30 patients in each group. After obtaining ethical approval on 14.12.2023, patients will be informed about the study procedure one day before surgery, and those who consent will sign an informed consent form. The QoR-15 questionnaire, used to assess anesthesia and surgical recovery quality, will be administered to patients preoperatively, 24 hours post-surgery, and on the 15th postoperative day. The results will be recorded for further analysis.
- Conditions
- Laparoscopic Inguinal Hernia Repair, Quality of Recovery (QoR-15), Postoperative Analgesia, Regional Anesthesia
- Keywords
- laparoscopic inguinal hernia repair, m-tapa block, tap block, quality of recovery, patient controlled analgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rate Score (NRS)
NRS is a 0 to 10 scale that describes pain from good to worst.
Measured: During the postoperative period, the NRS scores of patients in motion and at rest will be recorded at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Quality of recovery-15 (QoR-15) score
Quality of Recovery-15 (QoR-15) questionnaire, is used to measure anesthesia and surgical recovery quality
Measured: The QoR-15 questionnaire will be administered to participants before surgery, 24 hours after surgery, and on the 15th postoperative day.
Secondary outcomes (3)
Postoperative nausea and vomiting scale (PONV)
PONV is a 0 to 4 scale that describes nausea and vomiting from good to worst.
Measured: During the postoperative period, the nausea and vomiting scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Sedation score
Sedation score is a 0 to 3 scale that describes sedation from good to worst.
Measured: During the postoperative period, the sedation scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Pain Controlled Analgesia (PCA)
PCA includes 200mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock.
Measured: PACU 0,15, 30th minutes and postoperative 2, 4, 6, 12, 24th hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start10 Jan 2024
- Primary completion17 Oct 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Inguinal Hernia RepairStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnan SARIDEDE, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Oznur Demiroluk, Associate Professor, Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753240
- Sponsor's protocol ID
- FSMTRH-INAN
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392Ciftci B, Gungor H, Alver S, Akin AN, Ozdenkaya Y, Tulgar S. Clinical Experience for Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Five Patients. Dermatomal Evaluation and Application of Different Volumes: A Case Series and Review of Literature. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):354-357. doi: 10.4274/TJAR.2022.221042.
PubMed 37587679Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
PubMed 35430086Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
PubMed 36511494Alver S, Ciftci B, Gungor H, Golboyu BE, Ozdenkaya Y, Alici HA, Tulgar S. Efficacy of modified thoracoabdominal nerve block through perichondrial approach following laparoscopic inguinal hernia repair surgery: a randomized controlled trial. Braz J Anesthesiol. 2023 Sep-Oct;73(5):595-602. doi: 10.1016/j.bjane.2023.05.001. Epub 2023 May 16.
PubMed 37201747
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-Guided Abdominal Plane Blocks on Postoperative Pain and Quality of Recovery in Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06753240
- Acronym / sponsor ID
- FSMTRH-INAN
- Conditions
- Laparoscopic Inguinal Hernia Repair, Quality of Recovery (QoR-15), Postoperative Analgesia, Regional Anesthesia
- Keywords
- laparoscopic inguinal hernia repair, m-tapa block, tap block, quality of recovery, patient controlled analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 31 Dec 2024 (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.
In laparoscopic inguinal hernia surgeries, although the effects of classical transversus abdominis plane (TAP) and Modified thoracoabdominal nerve block through perichondrial approach (m-TAPA) blocks on perioperative pain control and opioid consumption have been evaluated in various studies using classical scaling methods, their impact on postoperative recovery quality remains an area open for further research. In this observational study, the investigator's primary goal is to evaluate the effects of lateral approach TAP and m-TAPA blocks, which are routinely used for postoperative analgesia, on postoperative pain and recovery quality in patients undergoing laparoscopic inguinal hernia surgery, using the QoR-15 scale. The investigator's secondary goal is to contribute to identifying the standard analgesia method that will reduce postoperative opioid use, nausea, and vomiting, and improve recovery quality.
Detailed description
Laparoscopic surgery is widely used in the repair of inguinal hernias, but it can cause moderate to severe postoperative pain. Perioperative pain management is essential for ensuring early mobilization of patients, reducing postoperative side effects and hospital stay durations, improving patient satisfaction, and preventing the development of chronic pain after surgery. The quality of postoperative recovery is influenced by various factors, such as the patient's preoperative characteristics, the type of surgery, the level of postoperative pain, and analgesic methods. In recent years, alongside traditional scales measuring classical parameters in evaluating postoperative recovery quality, new measurement tools focusing on patient satisfaction have been developed. One of these tools is the Quality of Recovery-15 (QoR-15) scale, which has been recommended by the European Society of Anaesthesiology for use in clinical studies investigating postoperative patient comfort and pain levels. This scale includes 15 questions across five different areas evaluating postoperative recovery from various perspectives: pain, physical comfort, physical independence, psychological support, and emotional state. The result is a score between 0 and 150, with higher scores indicating better recovery quality.
Ultrasound (USG)-guided abdominal plane blocks are an important part of multimodal analgesia due to their ease of application, ability to provide long-lasting postoperative analgesia, and potential to reduce opioid consumption. Various regional anesthesia techniques can be used for pain control following laparoscopic inguinal hernia repair surgeries (TransAbdominal Pre-Peritoneal approach-TAPP). Some of these techniques include the Transversus Abdominis Plane (TAP) block and the Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block. The TAP block is performed in the neurofascial plane between the internal oblique and transversus abdominis muscles, creating a dermatomal sensory block at the T6-L1 levels. It can be applied laterally, subcostally, or posteriorly. The Perichondrial Approach Modified Thoracoabdominal Plane (m-TAPA) block is used more recently in upper and lower abdominal surgeries to provide effective analgesia due to its wider dermatomal coverage. The m-TAPA block is performed under ultrasound guidance by injecting a local anesthetic between the costal cartilage and the transversus abdominis muscle, providing abdominal analgesia from T4-L1 along the anterior and lateral abdominal wall. Both TAP and m-TAPA blocks are regional analgesia techniques commonly applied in our daily practice after abdominal surgeries. The choice of regional anesthesia technique is determined based on the surgical region, type of surgery, and the experience of the anesthesia team.
This study includes 60 patients aged 18-65 years, classified in the American Society of Anesthesiologists (ASA) physical risk class I-III, who are scheduled to undergo elective laparoscopic inguinal hernia repair surgery under general anesthesia at the General Surgery Department of Fatih Sultan Mehmet Training and Research Hospital.Participants who are planning to receive M-TAPA block defines as Group M-TAPA, and those who receive lateral TAP block defines as Group TAP, with 30 patients in each group. After obtaining ethical approval on 14.12.2023, patients will be informed about the study procedure one day before surgery, and those who consent will sign an informed consent form. The QoR-15 questionnaire, used to assess anesthesia and surgical recovery quality, will be administered to patients preoperatively, 24 hours post-surgery, and on the 15th postoperative day. The results will be recorded for further analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions.
Key inclusion criteria (4 listed)
- Patients who will undergo laparoscopic unilateral inguinal hernia surgery under general anesthesia in elective conditions, by the General Surgery clinic between January 10, 2024 and October 17, 2024
- Aged between 18-65 years, with a Body Mass Index (BMI) < 35 kg/m²,
- Having an American Society of Anesthesiologists (ASA) physical risk score of I-III,
- Patients who have given informed consent.
Key exclusion criteria (11 listed)
- Patients who refuse to participate in the study
- Emergency surgeries
- Patients who will undergo recurrent or bilateral surgery
- Patients with a BMI ≥ 35 kg/m²
- Presence of local infection or hematoma at the application site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric Rate Score (NRS)
Time frame: During the postoperative period, the NRS scores of patients in motion and at rest will be recorded at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
NRS is a 0 to 10 scale that describes pain from good to worst.
Quality of recovery-15 (QoR-15) score
Time frame: The QoR-15 questionnaire will be administered to participants before surgery, 24 hours after surgery, and on the 15th postoperative day.
Quality of Recovery-15 (QoR-15) questionnaire, is used to measure anesthesia and surgical recovery quality
3 secondary outcomes
Postoperative nausea and vomiting scale (PONV)
Time frame: During the postoperative period, the nausea and vomiting scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Sedation score
Time frame: During the postoperative period, the sedation scores of patients will be assessed at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.
Pain Controlled Analgesia (PCA)
Time frame: PACU 0,15, 30th minutes and postoperative 2, 4, 6, 12, 24th hours]
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 11 Mar 2025.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- Background: PubMed 37587679Ciftci B, Gungor H, Alver S, Akin AN, Ozdenkaya Y, Tulgar S. Clinical Experience for Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Five Patients. Dermatomal Evaluation and Application of Different Volumes: A Case Series and Review of Literature. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):354-357. doi: 10.4274/TJAR.2022.221042.
- Background: PubMed 35430086Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- Background: PubMed 36511494Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
- Background: PubMed 37201747Alver S, Ciftci B, Gungor H, Golboyu BE, Ozdenkaya Y, Alici HA, Tulgar S. Efficacy of modified thoracoabdominal nerve block through perichondrial approach following laparoscopic inguinal hernia repair surgery: a randomized controlled trial. Braz J Anesthesiol. 2023 Sep-Oct;73(5):595-602. doi: 10.1016/j.bjane.2023.05.001. Epub 2023 May 16.
- 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.
Oznur Demiroluk, Associate Professor study director
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Inguinal Hernia Repair and Quality of Recovery (QoR-15), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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 11 Mar 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 Turkey (Türkiye). 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?
Numeric Rate Score (NRS) (time frame: During the postoperative period, the NRS scores of patients in motion and at rest will be recorded at 0, 15, and 30 minutes, as well as at 2, 4, 6, 12, and 24 hours in the ward.). The study lists 2 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 NCT06753240, which also lists 5 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 11 Mar 2025.