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Clinical Trials/NCT07469410
NCT07469410
Completed
Phase 3

Comparison Of Postoperative Analgesia In Landmark Guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block In Laparoscopic Cholecystectomy; A Randomized Controlled Trial

Patel Hospital, Pakistan1 site in 1 country60 target enrollmentStarted: June 1, 2025Last updated:

Overview

Phase
Phase 3
Status
Completed
Sponsor
Patel Hospital, Pakistan
Enrollment
60
Locations
1
Primary Endpoint
VAS score

Overview

Brief Summary

Postoperative pain after laparoscopic cholecystectomy remains clinically relevant. This double-blinded randomized controlled trial compares the analgesic efficacy of landmark-guided Erector Spinae Plane Block (ESPB) and subcostal transversus abdominis plane (STAP) block in 60 adult patients. Postoperative pain will be evaluated using the Visual Analogue Scale at multiple time points, along with rescue analgesic requirements and time to first analgesic request, to assess the effectiveness of these techniques in resource-limited settings.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients are both men and women.
  • Patients aged 18 to
  • Patients are scheduled for a laparoscopic cholecystectomy.
  • Patients with ASA Physical Status I or II. Finally, III.
  • Give consent.

Exclusion Criteria

  • Hypersensitivity to local anesthesia.
  • Infection at the block site.
  • Coagulation disorders.
  • BMI above 40kg/m
  • Patients with pregnancy.
  • Converted to open surgery.
  • Drain placement.
  • Neurological or psychiatric disorders that impair cooperation.
  • Patients are unwilling to cooperate.

Arms & Interventions

Experimental: Landmark-guided Erector Spinae Plane Block

Experimental

Patients will receive a landmark-guided erector spinae plane block on the right side at the T9 level with 30 mL of 0.25% ropivacaine after induction of general anesthesia.

Intervention: Landmark guided Erector Spinae Block (Drug)

landmark-guided Subcostal Transversus Abdominis Plane Block

Active Comparator

Patients will receive a landmark-guided Subcostal Transversus Abdominis Plane Block on the right side with 30 mL of 0.25% ropivacaine after induction of general anesthesia.

Intervention: Landmark guided Transversus Abdominis Plane Block (Drug)

Outcomes

Primary Outcomes

VAS score

Time Frame: From arrival in the post-anesthesia care unit (PACU) through 24 hours postoperatively, assessed at 30 minutes in PACU, and at 6 hours, 12 hours, and 24 hours after surgery.

Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

Secondary Outcomes

  • need for rescue analgesia and time for first analgesic request.(From completion of surgery through 24 hours postoperatively.)

Investigators

Sponsor
Patel Hospital, Pakistan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kulsoom Mehmood

FCPS Resident, Department of Anaesthesiology

Patel Hospital, Pakistan

Study Sites (1)

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