- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264855
M-TAPA vs. Combined M-TAPA + EXOP for Postoperative Pain in Laparoscopic Gynecologic Surgery
Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Şeyma Nur Güner Zengin, MD
- Phone Number: +90 212 414 71 71
- Email: snurguner@gmail.com
Study Contact Backup
- Name: Güneş Özlem Yıldız, Associate Professor
- Phone Number: +90 212 414 71 71
- Email: drgunesim@hotmail.com
Study Locations
-
-
Bakirkoy
-
Istanbul, Bakirkoy, Turkey (Türkiye), 34147
- Recruiting
- SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients scheduled for laparoscopic gynecologic surgery
- Age 18-90 years
- ASA physical status I-III
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group M
Participants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice.
|
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
Other Names:
|
|
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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
1, 2, 6, 12, and 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rescue Analgesic Requirement
Time Frame: First 24 hours after surgery
|
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.
|
First 24 hours after surgery
|
|
Quality of Recovery (QoR-15 Score)
Time Frame: Preoperative baseline and postoperative 24th hour
|
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 |
Preoperative baseline and postoperative 24th hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Nausea and Vomiting (PONV) Score
Time Frame: First 24 hours after surgery
|
Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes).
Scores will be compared between the two groups.
|
First 24 hours after surgery
|
|
Time to First Rescue Analgesic Request
Time Frame: First 24 hours after surgery
|
The time interval (in minutes) from the end of surgery to the first request for rescue analgesia will be recorded.
Rescue analgesia will consist of intravenous 100 mg tramadol administered when the patient reports an NRS pain score ≥ 4. Results will be compared between Group M and Group E.
|
First 24 hours after surgery
|
|
Dermatomal Spread (Pinprick Test)
Time Frame: 1, 2, 6, 12, and 24 hours after surgery
|
Sensory block distribution will be assessed using the pinprick test to evaluate dermatomal spread.
Results will be compared between Group M and Group E.
|
1, 2, 6, 12, and 24 hours after surgery
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tulgar 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.
- Gan 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.
- 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.
- Atsumi 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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