Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair

Comparison of Analgesic Effects of Ultrasound Guided Transversus Abdominis Plane Block With Bupivacaine and Bupivacaine With Morphine in Patient Undergoing Open Unilateral Inguinal Hernia Repair Under Spinal Anaesthesia

This study is conducted to determine whether morphine added to bupivacaine in ultrasound guided (USG) transversus abdominis plane (TAP) block has beneficial effects than bupivacaine alone in providing postoperative analgesia for inguinal hernia surgery.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Combination product: bupivacaine and morphine

Detailed Description

Total of forty adult patients of American Society of Anaesthesiologists (ASA) physical status ( PS) I - II scheduled for elective inguinal hernia surgery under spinal anaesthesia were recruited in this study after getting written informed consent. They were randomized to undergo ipsilateral USG TAP block with 20 ml of 0.25 % bupivacaine (group B) versus 20 ml of 0.25 % bupivacaine with 3 mg morphine (group BM). Patients were followed postoperatively for the 24 hours by a blinded investigator for monitoring of number of rescue analgesic consumed, duration of analgesia, numerical rating scale (NRS) at rest and on cough and any adverse effects.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Province No. 1
    • Dharān Bāzār, Province No. 1, Nepal, 56700
      • Purna kala Gurung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

ASA I to III Elective surgery

Exclusion Criteria:

• Patient's refusal
• BMI > 35 kg/m2 or < 18 kg/m2
• Allergic or contraindication to drugs used in study
• Coagulopathy
• Local site infection
• Spine deformity
• Uncooperative or psychological illness
• Inability to comprehend pain scale
• Drugs not injected in target area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine group; 0.25% bupivacaine 20 ml in TAP block	Combination product: bupivacaine and morphine; Bupivacaine group will receive 0.25% bupivacaine 20 ml in TAP block. Bupivacaine morphine group will receive 0.25% bupivacaine 20 ma with 3 mg morphine in TAP block.
Experimental: Bupivacaine morphine group; 0.25% bupivacaine 20 ml with 3 mg morphine in TAP block	Combination product: bupivacaine and morphine; Bupivacaine group will receive 0.25% bupivacaine 20 ml in TAP block. Bupivacaine morphine group will receive 0.25% bupivacaine 20 ma with 3 mg morphine in TAP block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Duration of postoperative analgesia • Postoperative analgesic requirement	Time from TAP block to first request of analgesic is considered as duration of analgesia Less requirement of rescue analgesic is considered as better	Till 24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• NRS for pain at rest and on cough between the groups • Any side effects	Group with higher NRS score is considered a less effective Group with increase side effects is considered as not acceptable	Till 24 hour after surgery

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences
• Investigators: Principal Investigator: Purna k Gurung, MS, B.P. Koirala Institute of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2018
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Inguinal hernia; Morphine,; TAP block,
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: IRC/1182/017

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
• product manufactured in and exported from the U.S.: No