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

NCT06837506 | Recruiting

• 1 other identifier: FMASU R03/2024/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound; Rectus Sheath Block; Intrathecal Morphine; Postoperative Analgesia; Total Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.

  24 hours postoperatively

Secondary Outcomes (6)

• Time to the first request for the rescue analgesia

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Degree of sedation

  Intraoperatively

• Degree of patient satisfaction

  24 hours postoperatively

• Time of hospital discharge

  28 days postoperatively

Study Arms (2)

Rectus sheath block group

EXPERIMENTAL

Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.

Drug: Rectus sheath block

Intrathecal morphine group

EXPERIMENTAL

Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

Drug: Intrathecal morphine

Interventions

Rectus sheath block DRUG

Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.

Also known as: Bupivacaine 0.25%

Rectus sheath block group

Intrathecal morphine DRUG

Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

Intrathecal morphine group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

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

Locations

EG (1)