M-TAPA vs. Combined M-TAPA + EXOP for Postoperative Pain in Laparoscopic Gynecologic Surgery
NCT ID: NCT07264855
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
86 participants
OBSERVATIONAL
2025-10-06
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group M
Participants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice.
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach
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
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.
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane 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).
Interventions
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Modified Thoracoabdominal Nerve Block Through Perichondrial Approach
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 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-90 years
* ASA physical status I-III
Exclusion Criteria
* 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
18 Years
90 Years
FEMALE
No
Sponsors
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
OTHER_GOV
Responsible Party
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Güneş Özlem Yıldız
Associate Professor, Principal Investigator
Locations
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SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakirkoy, Turkey (Türkiye)
Countries
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Central Contacts
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Güneş Özlem Yıldız, Associate Professor
Role: CONTACT
Phone: +90 212 414 71 71
Email: [email protected]
References
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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.
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.
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.
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.
Other Identifiers
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2025/312
Identifier Type: -
Identifier Source: org_study_id