Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy

Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial

This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Postoperative Analgesia; Intrathecal Morphine; Total Abdominal Hysterectomy; Rectus Sheath Block
• Intervention / Treatment: Drug: Rectus sheath block; Drug: Intrathecal morphine

Detailed Description

Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).

Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.

Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).

• Study Type: Interventional
• Enrollment (Estimated): 80
• 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 M Eldemerdash, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age: 18 - 65 years old.
• American Society of Anesthesiologists (ASA) physical status (I -II).
• Patients undergoing open total abdominal hysterectomy.

Exclusion Criteria:

• Hepatic, renal, or cardiac disease.
• Any known allergy to local anesthetic.
• Physical or mental conditions which may vague measuring 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rectus sheath block group; Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.	Drug: Rectus sheath block; Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.; Other Names: Bupivacaine 0.25%
Experimental: Intrathecal morphine group; Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.	Drug: Intrathecal morphine; Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	The 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
Time to the first request for the rescue analgesia	Time to the first request for the rescue analgesia (time from the end of surgery till first dose of morphine administrated)	24 hours postoperatively
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 after surgery over 24 hour using VAS scale at (post-anesthesia care unit, 2, 4, 6, 12, 18, and 24 h).	24 hours postoperatively
Degree of sedation	Sedation will be assessed using Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S): (5 Alert: Responds readily to name spoken in normal tone, 4: Lethargic response to name spoken in normal tone, 3: Responds only after name is called loudly and/or repeatedly, 2: Responds only after mild prodding or shaking ,1: Responds only after painful trapezius squeeze,0: Does not respond to painful trapezius squeeze).	Intraoperatively
Time of hospital discharge	Time of hospital discharge will be recorded from admission till the discharge from hospital.	28 days postoperatively
Incidence of adverse events	Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, 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; Analgesics; Analgesics, Opioid; Narcotics; Bupivacaine; Morphine
• Other Study ID Numbers: FMASU R03/2024/2025

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: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Access Criteria: After the end of study for one year.
• 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