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

Not Applicable

Recruiting

• Conditions: Ultrasound; Postoperative Analgesia; Rectus Sheath Block; Intrathecal Morphine; Total Abdominal Hysterectomy
• Interventions: Drug: Rectus sheath block; Drug: Intrathecal morphine

• Registration Number: NCT06837506
• Lead Sponsor: Ain Shams University

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.

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 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: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus sheath block group	Rectus sheath block	Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.
Intrathecal morphine group	Intrathecal morphine	Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from the end of surgery till 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 after surgery over 24 hour using VAS scale at (post-anesthesia care unit, 2, 4, 6, 12, 18, and 24 h).
Degree of patient satisfaction	24 hours postoperatively	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).
Time of hospital discharge	28 days postoperatively	Time of hospital discharge will be recorded from admission till the discharge from hospital.
Degree of sedation	Intraoperatively	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).
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, or any other complication will be recorded.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt