NCT07403682

Brief Summary

Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects. The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited. This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

February 4, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Laparoscopic cholecystectomyM-TAPA blockErector spinae plane block (ESPB)Regional anesthesiaPostoperative analgesiaOpioid consumption

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption in the First 24 Hours

    Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.

    within the first 24 hours postoperatively

Secondary Outcomes (7)

  • Pain intensity at rest (NRS)

    PACU, 3, 6, 12, 18, and 24 hours postoperatively

  • Pain intensity during movement (NRS)

    PACU, 3, 6, 12, 18, and 24 hours postoperatively

  • Rescue analgesic requirement

    Within the first 24 hours postoperatively

  • Postoperative nausea and vomiting (PONV)

    At postoperative hours 0, 6, 12, and 24

  • Time to first rescue analgesia

    Within the first 24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

M-TAPA Block

EXPERIMENTAL

An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Procedure: Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)

ESPB

EXPERIMENTAL

An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Procedure: erector spinae plane block (ESPB)

Interventions

An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

M-TAPA Block

An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

ESPB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18-65 years
  • ASA physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Refusal to participate
  • Known allergy to local anesthetics
  • Coagulation disorders or anticoagulant therapy
  • Infection at the injection site
  • Severe hepatic, renal, or cardiac disease
  • Chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants were blinded to treatment allocation. Postoperative outcome assessments, including pain scores, QoR-15, patient satisfaction, and postoperative nausea and vomiting, were performed by an independent investigator who was blinded to group allocation. The anesthesiologist performing the assigned block was aware of the intervention but was not involved in postoperative data collection or outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

March 3, 2026

Primary Completion

May 23, 2026

Study Completion

May 23, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations