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

Not Applicable

Recruiting

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

• Registration Number: NCT06837532
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Study Start: 2025-02-20
• Study First Posted: 2025-02-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided rectus sheath block group	Ultrasound-guided rectus sheath block	Patients will receive ultrasound-guided rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the end of surgery.
Surgical rectus sheath block group	Surgical rectus sheath block	Patients will receive a surgical rectus sheath block (20 ml bupivacaine 0.25%) bilaterally at the time of closure.
Local anesthesia infiltration group	Local anesthesia infiltration	Patients will receive local anesthesia infiltration at the end of surgery.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate	Till the end of surgery (Up to 4 hours)	Heart rate will be recorded preoperatively, before the block is performed, and every 15 minutes until the end of the surgery.
Mean arterial pressure	Till the end of surgery (Up to 4 hours)	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Degree of pain	24 hours postoperatively	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.
Degree of patient satisfaction	24 hours postoperatively	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).
Incidence of adverse events	24 hours postoperatively	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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt