NCT07479069

Brief Summary

his randomized controlled trial aims to evaluate the efficacy of the bilateral erector spinae plane (ESP) block in reducing postoperative opioid consumption in patients undergoing open abdominal surgeries under general anesthesia

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

Erector Spinae Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Opioid Consumption

    Assessed by the percentage of patients requiring rescue opioid analgesia. The need for rescue analgesia is determined by a Visual Analogue Score (VAS) greater than five

    Within the first 24 hours after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients receiving standard pain control treatment. Postoperatively, patients receive 1000 mg of IV paracetamol every 6 hours. If a patient reports a Visual Analogue Score (VAS) exceeding five, they will receive rescue analgesia consisting of nalbuphine 4mg

Drug: Standard Postoperative Analgesia

Erector Spinae Block Group

EXPERIMENTAL

Patients receiving bilateral ESP block in addition to standard pain control treatment

Procedure: Bilateral Erector Spinae Plane (ESP) BlockDrug: Standard Postoperative Analgesia

Interventions

Administered after the induction of general anesthesia and before the surgical incision. Local anesthetic (0.25% ropivacaine or 0.25% bupivacaine) will be injected for a total of 20-40 mL

Erector Spinae Block Group

Patients receive 1000 mg of IV paracetamol every 6 hours postoperatively. If a patient experiences a Visual Analogue Score (VAS) of more than five at any time, they receive rescue analgesia in the form of nalbuphine 4mg

Control GroupErector Spinae Block Group

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiology (ASA) stage I-II.
  • Scheduled for abdominal surgery due to any indication.

You may not qualify if:

  • History of Diabetes
  • History of neuropathic diseases
  • History of gastrointestinal bleeding, peptic ulcer, or inflammatory bowel disease
  • History of long-term nonsteroidal anti-inflammatory
  • History of chronic opioid analgesic use
  • History of severe hepatic or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

October 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations