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

NCT06882369 | Active Not Recruiting Phase 1

• 1 other identifier: TAP vs. morphine vs. both
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain Management

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic request

  Time (in hours) until the patient demand additional analgesia.

  24 hours

Secondary Outcomes (3)

• Total analgesic consumption

  24 hours

• Time to ambulation

  24 hours

• complications

  24 hours

Study Arms (3)

TAP block

ACTIVE COMPARATOR

Bilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.

Procedure: TAP Block; Drug: spinal anesthesia

Intrathecal Morphine

ACTIVE COMPARATOR

Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia).

Drug: Intrathecal morphine injection; Drug: spinal anesthesia

Combined

ACTIVE COMPARATOR

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.

Procedure: TAP Block; Drug: Intrathecal morphine injection; Drug: spinal anesthesia

Interventions

TAP Block PROCEDURE

The transabdominal plane (TAP) block is a regional anesthesia technique used for postoperative pain management in abdominal wall procedures, providing somatic analgesia to the anterior and lateral abdominal walls

Combined; TAP block

Intrathecal morphine injection DRUG

Intrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia

Combined; Intrathecal Morphine

spinal anesthesia DRUG

intrathecal injection of bupivacaine

Combined; Intrathecal Morphine; TAP block

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Medicine, Minia University

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• sohair Adeeb, assist.prof.

  Minia University, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 18, 2025
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)