NCT07869316

Brief Summary

Laparoscopic cholecystectomy is commonly associated with moderate postoperative pain, particularly during the early postoperative period. Inadequate postoperative analgesia may negatively affect patient comfort and recovery, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing laparoscopic cholecystectomy. Subcostal transversus abdominis plane (TAP) block is a regional anesthesia technique used to provide analgesia for upper abdominal surgery. However, its analgesic coverage may be insufficient in some patients because of the complex innervation of the upper abdominal wall. The recto-intercostal fascial plane block has been described as a fascial plane block targeting the anterior branches of the thoracoabdominal nerves and may provide additional analgesic benefit when combined with subcostal TAP block. This study aims to compare the postoperative analgesic efficacy of bilateral subcostal TAP block alone with that of bilateral subcostal TAP block combined with recto-intercostal fascial plane block in patients undergoing elective laparoscopic cholecystectomy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 14, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 6, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Laparoscopic cholecystectomyTransversus abdominis plane blockRecto-intercostal fascial plane block

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Pain will be assessed at rest using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain). Pain assessment will be done at 6th hour after surgery.

    On the operation day

Secondary Outcomes (2)

  • Pain Scores

    On the operation day

  • Total Postoperative Opioid Consumption During the First 24 Hours AfterSurgery

    On the operation day

Study Arms (2)

Subcostal TAP Block

ACTIVE COMPARATOR

Following induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine.

Procedure: Subcostal TAP Block

Subcostal TAP Block + Recto-Intercostal Fascial Plane Block

ACTIVE COMPARATOR

Following induction of general anesthesia and before surgical incision, participants will receive a bilateral ultrasound-guided subcostal transversus abdominis plane block using a total volume of 40 mL of 0.20% bupivacaine together with a bilateral ultrasound-guided recto-intercostal fascial plane block using a total volume of 30 mL of 0.20% bupivacaine.

Procedure: Subcostal TAP Block + Recto-Intercostal Fascial Plane Block

Interventions

Following induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided subcostal transversus abdominis plane block will be performed. A total volume of 40 mL of 0.20% bupivacaine will be administered.

Subcostal TAP Block

Following induction of general anesthesia and before surgical incision, a bilateral ultrasound-guided subcostal transversus abdominis plane block will be performed using a total volume of 40 mL of 0.20% bupivacaine. In addition, a bilateral ultrasound-guided recto-intercostal fascial plane block will be performed using a total volume of 30 mL of 0.20% bupivacaine.

Subcostal TAP Block + Recto-Intercostal Fascial Plane Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • With a body mass index (BMI) between 18 and 30 kg/m².
  • American Society of Anesthesiologists (ASA) physical status I, II, or III
  • Scheduled to undergo elective laparoscopic cholecystectomy

You may not qualify if:

  • Age younger than 18 years or older than 80 years
  • With a body mass index (BMI) below 18 or above 30 kg/m
  • American Society of Anesthesiologists (ASA) physical status IV or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 9, 2026

Study Start (Estimated)

October 14, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 29, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Locations