TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH

Phase 1

Active, not recruiting

• Conditions: Post-operative Pain Management
• Interventions: Procedure: TAP Block; Drug: Intrathecal morphine injection; Drug: spinal anesthesia

• Registration Number: NCT06882369
• Lead Sponsor: Minia University

Brief Summary

This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Female patients aged 30 to 70 years.
• Elective total abdominal hysterectomy.
• ASA physical status I or II.
• Willingness to provide informed consent.

Exclusion Criteria

• Refusal of the block.
• Allergy to study medications.
• Preexisting coagulation disorders.
• Local infection at the site of needle insertion.
• Uncontrolled respiratory or cardiac disorders.
• Impaired kidney or liver function.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block	TAP Block	Bilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.
TAP block	spinal anesthesia	Bilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.
Intrathecal Morphine	Intrathecal morphine injection	Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia).
Intrathecal Morphine	spinal anesthesia	Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia).
Combined	TAP Block	Intrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.
Combined	Intrathecal morphine injection	Intrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.
Combined	spinal anesthesia	Intrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request	24 hours	Time (in hours) until the patient demand additional analgesia.

Secondary Outcome Measures

Name	Time	Method
Total analgesic consumption	24 hours	Cumulative postoperative analgesic consumption
Time to ambulation	24 hours	Time (in hours) from arrival in the PACU until the patient was able to walk.
complications	24 hours	Incidence of nausea, vomiting, pruritus, respiratory depression, hematoma, infection or hemodynamic instability

Trial Locations

Locations (1)

Faculty of Medicine, Minia University; 🇪🇬 Minya, El Minya, Egypt