Postoperative PainNCT07264855
M-TAPA vs. Combined M-TAPA + EXOP for Postoperative Pain in Laparoscopic Gynecologic Surgery
An observational study of Postoperative Pain and Laparoscopic Gynecologic Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic gynecologic surgery is less invasive than open surgery, but many patients still experience pain after the procedure. M-TAPA and EXOP are ultrasound-guided regional anesthesia techniques used to reduce abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Postoperative Pain, Laparoscopic Gynecologic Surgery
- What is being tested?
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane Block
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to Oct 2026
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients undergoing laparoscopic gynecologic surgery.
Who may be able to join
- Patients scheduled for laparoscopic gynecologic surgery
- Age 18-90 years
- ASA physical status I-III
Who cannot join
- Contraindications to block procedures (coagulopathy, anticoagulant therapy, local infection at needle insertion site, etc.)
- Severe cardiac, renal, hepatic, hematologic, neurologic, or psychiatric disease
- Allergy to amide-type local anesthetics
- Chronic pain, narcotic or alcohol dependence
- BMI ≥ 35 kg/m²
- Pregnancy
- Refusal to participate
- Conversion from laparoscopy to laparotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakirkoy, 34147
About this study
Official title: Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries
Laparoscopic gynecologic surgery is less invasive than open surgery, but many patients still experience pain after the procedure. M-TAPA and EXOP are ultrasound-guided regional anesthesia techniques used to reduce abdominal pain. Previous research suggests that M-TAPA provides effective pain relief on the anterior abdominal wall, while EXOP may help reduce pain in the lateral abdominal region. This study aims to determine whether combining M-TAPA with EXOP provides better postoperative pain control than using M-TAPA alone. The study will compare pain scores during the first 24 hours after surgery, the need for rescue analgesic medication, and recovery quality using the QoR-15 questionnaire. All procedures are part of routine clinical care, and no experimental drugs or devices are used.
Read the detailed description
In routine practice at our institution, anesthesia clinicians performing gynecologic laparoscopic procedures administer either modified thoracoabdominal nerve block through perichondrial approach (M-TAPA Block) alone or a combination of M-TAPA and external oblique muscle plane (EXOP) blocks, based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either M-TAPA or M-TAPA + EXOP will be included and evaluated observationally. Block types other than these two will not be included.
All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, administering the QoR-15 questionnaire, and evaluating sensory block distribution using the pinprick test.
Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. The researcher obtains informed consent, records demographic data, and administers the preoperative QoR-15 questionnaire.
In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied, intravenous access is established, and crystalloid infusion is initiated. Anesthesia induction is performed using propofol, an opioid, and a neuromuscular blocking agent, followed by endotracheal intubation. General anesthesia is maintained with sevoflurane in an oxygen-air mixture. Laparoscopic surgery is performed with gradual CO₂ insufflation, maintaining intra-abdominal pressure below 12 mmHg.
For postoperative analgesia, all patients routinely receive 1 g intravenous paracetamol and 100 mg tramadol. After surgery, neuromuscular blockade is reversed and patients are transferred to the post-anesthesia care unit (PACU).
After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9. All patients receive 1 g intravenous paracetamol every 8 hours as per routine protocol. Postoperative pain is assessed by the pain team using the 0-10 Numeric Rating Scale (NRS).
Postoperative nausea and vomiting (PONV) are assessed and intravenous ondansetron 4 mg is administered for PONV ≥2. Patients without PONV are encouraged to mobilize early and resume oral intake. Discharge is permitted once symptoms resolve; however, all patients remain hospitalized for at least 24 hours.
As an additional study-related procedure, the researcher evaluates dermatomal spread using the pinprick test and administers the QoR-15 questionnaire at 24 hours.
- Being tested
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach, Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane Block
- Keywords
- M-TAPA block, External Oblique Plane Block (EXOP), Postoperative pain, Laparoscopic gynecologic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachProcedure or surgery
Also called M-TAPA Block
A bilateral modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is performed under ultrasound guidance in the supine position prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned at the level of the 10th rib in the sagittal plane. The needle is advanced to the fascial plane between the internal oblique and transversus abdominis muscles. Following negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.25% bupivacaine is injected bilaterally (total volume 40 mL). The procedure is performed by anesthesiologists experienced in gynecologic surgery, without researcher involvement in clinical decision-making
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane BlockProcedure or surgery
Also called M-TAPA + EXOP Block
Following completion of the bilateral M-TAPA block, an external oblique muscle plane (EXOP) block is performed under ultrasound guidance as part of routine clinical practice. The ultrasound probe is positioned over the lateral abdominal wall between the costal margin and iliac crest. After negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.125% bupivacaine is injected on each side into the fascial plane superficial to the external oblique muscle (total volume 80 mL).
| Study group | Role | What they receive |
|---|---|---|
| Group M | Participants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice. Receives: Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach | |
| Group E | Participants who received a combined bilateral M-TAPA block and external oblique plane (EXOP) block performed pre-extubation as part of routine anesthesia practice. Receives: Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (NRS)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and will be compared between Group M and Group E.
The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Measured: 1, 2, 6, 12, and 24 hours after surgery
Secondary outcomes (2)
Rescue Analgesic Requirement
The total amount of rescue analgesic medication (intravenous tramadol, mg) administered in the first 24 hours will be recorded. Requirements will be compared between Group M and Group E.
Measured: First 24 hours after surgery
Quality of Recovery (QoR-15 Score)
The quality of recovery will be assessed using the validated QoR-15 questionnaire. Scores will be compared between Group M and Group E to evaluate the impact of each block technique on postoperative recovery.
QoR-15 total score ranges from 0 to 150; higher scores indicate better quality of recovery
Measured: Preoperative baseline and postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start25 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Güneş Özlem Yıldız, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264855
- Sponsor's protocol ID
- 2025/312
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study contains personal health information and no regulatory or ethics approval has been obtained for external data sharing.
Publications
Liu S, Wang Z, Long X, Fleishman A, Huang X, Wu Q, Gershman B, Olumi AF. Single black men have the worst prognosis with localized prostate cancer. Can J Urol. 2022 Feb;29(1):10992-11002.
PubMed 35150221Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
PubMed 30639940Atsumi C, Aikawa K, Takahashi K, Okada K, Morimoto Y. The comparison of postoperative analgesic requirements between modified thoracoabdominal nerve block through perichondrial approach versus wound infiltration analgesia in patients undergoing gynecological laparoscopic surgery: a retrospective, exploratory study. JA Clin Rep. 2023 Jun 24;9(1):39. doi: 10.1186/s40981-023-00632-w.
PubMed 37354282Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries
- ClinicalTrials.gov ID
- NCT07264855
- Acronym / sponsor ID
- 2025/312
- Keywords
- M-TAPA block, External Oblique Plane Block (EXOP), Postoperative pain, Laparoscopic gynecologic surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 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.
Laparoscopic gynecologic surgery is less invasive than open surgery, but many patients still experience pain after the procedure. M-TAPA and EXOP are ultrasound-guided regional anesthesia techniques used to reduce abdominal pain. Previous research suggests that M-TAPA provides effective pain relief on the anterior abdominal wall, while EXOP may help reduce pain in the lateral abdominal region. This study aims to determine whether combining M-TAPA with EXOP provides better postoperative pain control than using M-TAPA alone. The study will compare pain scores during the first 24 hours after surgery, the need for rescue analgesic medication, and recovery quality using the QoR-15 questionnaire. All procedures are part of routine clinical care, and no experimental drugs or devices are used.
Detailed description
In routine practice at our institution, anesthesia clinicians performing gynecologic laparoscopic procedures administer either modified thoracoabdominal nerve block through perichondrial approach (M-TAPA Block) alone or a combination of M-TAPA and external oblique muscle plane (EXOP) blocks, based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either M-TAPA or M-TAPA + EXOP will be included and evaluated observationally. Block types other than these two will not be included.
All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, administering the QoR-15 questionnaire, and evaluating sensory block distribution using the pinprick test.
Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. The researcher obtains informed consent, records demographic data, and administers the preoperative QoR-15 questionnaire.
In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied, intravenous access is established, and crystalloid infusion is initiated. Anesthesia induction is performed using propofol, an opioid, and a neuromuscular blocking agent, followed by endotracheal intubation. General anesthesia is maintained with sevoflurane in an oxygen-air mixture. Laparoscopic surgery is performed with gradual CO₂ insufflation, maintaining intra-abdominal pressure below 12 mmHg.
For postoperative analgesia, all patients routinely receive 1 g intravenous paracetamol and 100 mg tramadol. After surgery, neuromuscular blockade is reversed and patients are transferred to the post-anesthesia care unit (PACU).
After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9. All patients receive 1 g intravenous paracetamol every 8 hours as per routine protocol. Postoperative pain is assessed by the pain team using the 0-10 Numeric Rating Scale (NRS).
Postoperative nausea and vomiting (PONV) are assessed and intravenous ondansetron 4 mg is administered for PONV ≥2. Patients without PONV are encouraged to mobilize early and resume oral intake. Discharge is permitted once symptoms resolve; however, all patients remain hospitalized for at least 24 hours.
As an additional study-related procedure, the researcher evaluates dermatomal spread using the pinprick test and administers the QoR-15 questionnaire at 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | – | Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachParticipants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice. |
| Group E | – | Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane BlockParticipants who received a combined bilateral M-TAPA block and external oblique plane (EXOP) block performed pre-extubation as part of routine anesthesia practice. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients undergoing laparoscopic gynecologic surgery.
Key inclusion criteria (3 listed)
- Patients scheduled for laparoscopic gynecologic surgery
- Age 18-90 years
- ASA physical status I-III
Key exclusion criteria (8 listed)
- Contraindications to block procedures (coagulopathy, anticoagulant therapy, local infection at needle insertion site, etc.)
- Severe cardiac, renal, hepatic, hematologic, neurologic, or psychiatric disease
- Allergy to amide-type local anesthetics
- Chronic pain, narcotic or alcohol dependence
- BMI ≥ 35 kg/m²
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 |
|---|---|---|
| Modified Thoracoabdominal Nerve Block Through Perichondrial ApproachAlso: M-TAPA BlockA bilateral modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is performed under ultrasound guidance in the supine position prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned at the level of the 10th rib in the sagittal plane. The needle is advanced to the fascial plane between the internal oblique and transversus abdominis muscles. Following negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.25% bupivacaine is injected bilaterally (total volume 40 mL). The procedure is performed by anesthesiologists experienced in gynecologic surgery, without researcher involvement in clinical decision-making | Procedure or surgery | Group M |
| Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane BlockAlso: M-TAPA + EXOP BlockFollowing completion of the bilateral M-TAPA block, an external oblique muscle plane (EXOP) block is performed under ultrasound guidance as part of routine clinical practice. The ultrasound probe is positioned over the lateral abdominal wall between the costal margin and iliac crest. After negative aspiration and confirmation of correct plane identification with hydrodissection, 20 mL of 0.125% bupivacaine is injected on each side into the fascial plane superficial to the external oblique muscle (total volume 80 mL). | Procedure or surgery | Group E |
Primary outcome
Postoperative Pain Score (NRS)
Time frame: 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and will be compared between Group M and Group E. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
2 secondary outcomes
Rescue Analgesic Requirement
Time frame: First 24 hours after surgery
Quality of Recovery (QoR-15 Score)
Time frame: Preoperative baseline and postoperative 24th hour
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 4 Jun 2026.
- Background: PubMed 35150221Liu S, Wang Z, Long X, Fleishman A, Huang X, Wu Q, Gershman B, Olumi AF. Single black men have the worst prognosis with localized prostate cancer. Can J Urol. 2022 Feb;29(1):10992-11002.
- Background: PubMed 30639940Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
- Background: PubMed 37354282Atsumi C, Aikawa K, Takahashi K, Okada K, Morimoto Y. The comparison of postoperative analgesic requirements between modified thoracoabdominal nerve block through perichondrial approach versus wound infiltration analgesia in patients undergoing gynecological laparoscopic surgery: a retrospective, exploratory study. JA Clin Rep. 2023 Jun 24;9(1):39. doi: 10.1186/s40981-023-00632-w.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study contains personal health information and no regulatory or ethics approval has been obtained for external data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Pain and Laparoscopic Gynecologic Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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?
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?
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?
Postoperative Pain Score (NRS) (time frame: 1, 2, 6, 12, and 24 hours after surgery). 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 NCT07264855, which also lists 4 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 4 Jun 2026.