Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery

NCT05179928 | Recruiting

• 1 other identifier: DTH: 21004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes. Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses. ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them. Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.

Conditions

Post Operative Pain

Keywords

Erector Spinae Plane Block; Rectus Sheath Block; Regional Analgesia

Outcome Measures

Primary Outcomes (1)

• Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)

  The time interval between the block performance and the first request of postoperative analgesia

  24 hours after block performance

Secondary Outcomes (3)

• Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)

  24 hours after block performance

• Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)

  24 hours after block performance

• Number of participants and Rate of Postoperative Complications

  24 hours after block performance

Study Arms (2)

Group E (n=30)

ACTIVE COMPARATOR

Erector Spinae Plane Block

Procedure: Erector Spinae Plane Block (ESPB)

Group R (n=30)

ACTIVE COMPARATOR

Rectus Sheath Block

Procedure: Rectus Sheath Block (RSB)

Interventions

Erector Spinae Plane Block (ESPB) PROCEDURE

Postoperative Bilateral Ultrasound-guided ESPB

Group E (n=30)

Rectus Sheath Block (RSB) PROCEDURE

Postoperative Bilateral Ultrasound-guided RSB

Group R (n=30)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 21 to 60 years
• Body Mass Index (BMI) \< 35 kg/m²

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status \> II
• Age \< 21 years or \> 60 years
• Body Mass Index (BMI) ≥ 35
• Local infection at the puncture site
• Altered mental status
• Pregnant women
• Allergy to study drugs
• Chronic pain
• Coagulation abnormalities or on anticoagulants
• Severe hepatic or kidney disease

Sponsors & Collaborators

• Damanhour Teaching Hospital: lead

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed M Shaat, MD

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Shaat, MD

CONTACT

00201223482709; ahmedshaat99@gmail.com

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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: August 1, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-07

Locations

EG (1)