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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07264855
Enrollment
86
Registered
2025-12-04
Start date
2025-11-25
Completion date
2026-10-31
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Laparoscopic Gynecologic Surgery

Keywords

M-TAPA block, External Oblique Plane Block (EXOP), Postoperative pain, Laparoscopic gynecologic surgery

Brief 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. 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.

Interventions

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

PROCEDUREModified 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).

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Score (NRS)1, 2, 6, 12, and 24 hours after surgeryPostoperative 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.

Secondary

MeasureTime frameDescription
Rescue Analgesic RequirementFirst 24 hours after surgeryThe 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.
Quality of Recovery (QoR-15 Score)Preoperative baseline and postoperative 24th hourThe 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

Other

MeasureTime frameDescription
Time to First Rescue Analgesic RequestFirst 24 hours after surgeryThe 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.
Dermatomal Spread (Pinprick Test)1, 2, 6, 12, and 24 hours after surgerySensory block distribution will be assessed using the pinprick test to evaluate dermatomal spread. Results will be compared between Group M and Group E.
Postoperative Nausea and Vomiting (PONV) ScoreFirst 24 hours after surgeryPostoperative 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactŞeyma Nur Güner Zengin, MD
snurguner@gmail.com+90 212 414 71 71
Backup ContactGüneş Özlem Yıldız, Associate Professor
drgunesim@hotmail.com+90 212 414 71 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026