Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy

NCT06837532 | Recruiting

• 1 other identifier: FMASU R23/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to compare the efficacy and safety of the effectiveness and safety of ultrasound-guided surgical rectus sheath block and local anesthetic infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.

Conditions

Ultrasound; Surgical; Rectus Sheath Block; Local Anesthesia Infiltration; Postoperative Analgesia; Total Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)\> 3 to be repeated after 30 min if pain persists until the VAS \< 4.

  24 hours postoperatively

Secondary Outcomes (6)

• Heart rate

  Till the end of surgery (Up to 4 hours)

• Mean arterial pressure

  Till the end of surgery (Up to 4 hours)

• Time to the first request for the rescue analgesia

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (3)

Ultrasound-guided rectus sheath block group

EXPERIMENTAL

Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.

Drug: Ultrasound-guided rectus sheath block

Surgical rectus sheath block group

EXPERIMENTAL

Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.

Drug: Surgical rectus sheath block

Local anesthesia infiltration group

EXPERIMENTAL

Patients will receive local anesthesia infiltration at the end of surgery.

Drug: Local anesthesia infiltration

Interventions

Ultrasound-guided rectus sheath block DRUG

Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.

Also known as: Bupivacaine

Ultrasound-guided rectus sheath block group

Surgical rectus sheath block DRUG

Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.

Also known as: Bupivacaine

Surgical rectus sheath block group

Local anesthesia infiltration DRUG

Patients will receive local anesthesia infiltration at the end of surgery.

Also known as: Bupivacaine

Local anesthesia infiltration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women scheduled for elective total abdominal hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years old.
• American Society of Anesthesiologists (ASA) physical status I - II.
• Patients scheduled for elective total abdominal hysterectomy under general anesthesia.

You may not qualify if:

• Hepatic, renal or cardiac disease.
• Any known allergy to local anesthetic.
• Physical or mental conditions which may vaguely measure postoperative pain following surgery.
• History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Sarah A Afifi, MD

CONTACT

0501035864; Sarah606060@gmail.com

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: Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)