NCT07264855

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2025Oct 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 6, 2026

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

November 24, 2025

Last Update Submit

January 4, 2026

Conditions

Keywords

M-TAPA blockExternal Oblique Plane Block (EXOP)Postoperative painLaparoscopic gynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    1, 2, 6, 12, and 24 hours after surgery

Secondary Outcomes (2)

  • Rescue Analgesic Requirement

    First 24 hours after surgery

  • Quality of Recovery (QoR-15 Score)

    Preoperative baseline and postoperative 24th hour

Other Outcomes (3)

  • Time to First Rescue Analgesic Request

    First 24 hours after surgery

  • Dermatomal Spread (Pinprick Test)

    1, 2, 6, 12, and 24 hours after surgery

  • Postoperative Nausea and Vomiting (PONV) Score

    First 24 hours after surgery

Study Arms (2)

Group M

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

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.

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

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

Also known as: M-TAPA Block
Group M

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).

Also known as: M-TAPA + EXOP Block
Group E

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult female patients undergoing laparoscopic gynecologic surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female patients undergoing laparoscopic gynecologic surgery.

You may qualify if:

  • Patients scheduled for laparoscopic gynecologic surgery
  • Age 18-90 years
  • ASA physical status I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35150221BACKGROUND
  • 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.

    PMID: 30639940BACKGROUND
  • 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.

    PMID: 37354282BACKGROUND
  • 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.

    PMID: 29026331BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Şeyma Nur Güner Zengin, MD

CONTACT

Güneş Özlem Yıldız, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 4, 2025

Study Start

November 25, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 6, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations