NCT07750769

Brief Summary

laparoscopic cholecystectomy (LC) is often accompanied by moderate-to-severe postoperative pain. opioid-free anesthesia (OFA) consists of a variety of non-opioid narcotic drugs and techniques.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

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

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2028

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Analgesia After Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia

    Assessed in microgram

    The first six hours after surgery

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol

Procedure: EOI with OFA

Group II

PLACEBO COMPARATOR

Patients will receive an opioid-free anesthesia (OFA) protocol

Drug: OFA

Interventions

EOI with OFAPROCEDURE

Patients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol

Group I
OFADRUG

Patients will receive an opioid-free anesthesia (OFA) protocol

Group II

Eligibility Criteria

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

You may qualify if:

  • Adult patients scheduled for elective laparoscopic cholecystectomy (LC) surgery under general anesthesia, American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 65 years old of either sex

You may not qualify if:

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or known allergy to amide local anesthetics)
  • Pregnancy or breastfeeding women
  • Body mass index (BMI) \> 35 Kg/m2
  • History of hepatic, renal, or cardiac disease
  • Chronic opioid use, or history of chronic pain (pain present for more than 6 months)
  • Thoracic deformity
  • Neuropsychiatric disorders
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seham Seham Moeen, M.D.

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seham M Moeen, M.D.

CONTACT

01006386324seham.moeen@aun.edu.eg

Mohamed R Shaaban, Msc.

CONTACT

01140541916mohamedrefaat@aun.edu.eg

Study Design

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

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

October 15, 2028

Study Completion (Estimated)

October 15, 2028

Last Updated

August 6, 2026

Record last verified: 2026-08