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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Postoperative Analgesia; Total Abdominal Hysterectomy; Rectus Sheath Block; Surgical; Local Anesthesia Infiltration
• Intervention / Treatment: Drug: Ultrasound-guided rectus sheath block; Drug: Surgical rectus sheath block; Drug: Local anesthesia infiltration

Detailed Description

Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort.

Local anesthetic infiltration (LAI) at the end of surgery is one of the most common technique employed in laparotomies for postoperative analgesia.

Rectus sheath block (RSB) has been used as a part of multimodal analgesia, especially when neuraxial techniques are unsuitable.The RSB was used to achieve peri-operative relaxation of the anterior abdominal wall.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah A Afifi, MD; Phone Number: 0501035864; Email: Sarah606060@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Sarah A Afifi, MD; Phone Number: 0501035864; Email: Sarah606060@gmail.com
    • Principal Investigator: Sondos Afifi, MD
    • Principal Investigator: Ahmed Eldemerdash, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-guided rectus sheath block group; 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; Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.; Other Names: Bupivacaine
Experimental: Surgical rectus sheath block group; Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.	Drug: Surgical rectus sheath block; Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.; Other Names: Bupivacaine
Experimental: Local anesthesia infiltration group; Patients will receive local anesthesia infiltration at the end of surgery.	Drug: Local anesthesia infiltration; Patients will receive local anesthesia infiltration at the end of surgery.; Other Names: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first request for the rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).	24 hours postoperatively
Heart rate	Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.	Till the end of surgery (Up to 4 hours)
Mean arterial pressure	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery (Up to 4 hours)
Degree of pain	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 2, 4, 6, 12, 18, and 24h postoperatively.	24 hours postoperatively
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, urinary retention, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: FMASU R23/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No