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

Efficacy Of Transversus Abdominis Plane Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following Total Abdominal Hysterectomy.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-operative Pain Management
• Intervention / Treatment: Procedure: TAP Block; Drug: spinal anesthesia; Drug: Intrathecal morphine injection

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • El Minya
    • Minya, El Minya, Egypt, 61111
      • Faculty of medicine, minia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: TAP Block; 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; Drug: spinal anesthesia; intrathecal injection of bupivacaine
Active Comparator: Intrathecal Morphine; Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia).	Drug: spinal anesthesia; intrathecal injection of bupivacaine; Drug: Intrathecal morphine injection; Intrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia
Active Comparator: Combined; 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; 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; Drug: spinal anesthesia; intrathecal injection of bupivacaine; Drug: Intrathecal morphine injection; Intrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic request	Time (in hours) until the patient demand additional analgesia.	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: sohair Adeeb, assist.prof., Minia University, faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: TAP vs. morphine vs. both

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No