NCT07276646

Brief Summary

This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress70%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

November 29, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 29, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

retrosuperior costotransverse ligament blockerector spinae blocklaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • The time to first call to rescue analgesia

    The time to first call to rescue analgesia( the interval between the block injection till the NRS more than or equal 4) (naluphine) will be recorded

    24 hours

Secondary Outcomes (7)

  • To assess block characteristics (block performance time)

    1 hour

  • Total intraoperative fentanyl consumption

    duration of surgery (up to 2 hours)

  • Pain intensity by Numerical Rating Scale

    30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative

  • total amount of rescue analgesia

    24 hours

  • Intraoperative hemodynamics (Heart Rate and Mean Arterial Pressure)

    every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery

  • +2 more secondary outcomes

Study Arms (2)

Retrosuperior costotransverse ligament block group

ACTIVE COMPARATOR

The patient will receive retrosuperior costotransverse ligament block

Procedure: Retrosuperior costotransverse ligament block group

Erector spinae block group

ACTIVE COMPARATOR

The patient will receive erector spinae block.

Procedure: Erector spinae block group

Interventions

The patient will receive retrosuperior costotransverse ligament block

Retrosuperior costotransverse ligament block group

The patient will receive erector spinae block.

Erector spinae block group

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patient acceptance
  • Age: 21-64 years old.
  • Sex: both sexes.
  • Physical status: ASA I \& II.
  • Body mass index (BMI): 18.5 - 30 kg/m2.
  • Type of operations: elective laparoscopic cholecystectomy.
  • Duration of surgery not more than 2 hours.

You may not qualify if:

  • Known hypersensitivity to lidocaine or bupivacaine.
  • Patients with respiratory insufficiency.
  • Coagulation disorders or taking drugs affect surgical hemostasis.
  • \. Patients with pre-existing neurological deficits. 8. Uncooperative patient or with altered mental status. 9. Patient with advanced cardiovascular or respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of human medicine, Zagazig university, Zagazig

Zagazig, Egypt

RECRUITING

Central Study Contacts

Dina Salem, MD

CONTACT

Marwa Medhat, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
anesthesiologist not sharing in the study will assess outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Achievement of high-quality perioperative opioid-sparing effect and postoperative analgesia for laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction by comparing retrosuperior costotransverse ligament block and erector spinae block in laparoscopic cholecystectomy
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations