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Clinical Trials/NCT07264855
NCT07264855
Recruiting
Not Applicable

Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 site in 1 country86 target enrollmentStarted: November 25, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Enrollment
86
Locations
1
Primary Endpoint
Postoperative Pain Score (NRS)

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

Group M

Participants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice.

Intervention: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (Procedure)

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.

Intervention: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane Block (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Rescue Analgesic Requirement(First 24 hours after surgery)
  • Quality of Recovery (QoR-15 Score)(Preoperative baseline and postoperative 24th hour)

Investigators

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Güneş Özlem Yıldız

Associate Professor, Principal Investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Sites (1)

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