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

NCT05379374 | Completed DMC

• 1 other identifier: IRC/1182/017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia

Keywords

TAP block,; Morphine,; Inguinal hernia

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

• • NRS for pain at rest and on cough between the groups • Any side effects

  Till 24 hour after surgery

Study Arms (2)

Bupivacaine group

ACTIVE COMPARATOR

0.25% bupivacaine 20 ml in TAP block

Combination Product: bupivacaine and morphine

Bupivacaine morphine group

EXPERIMENTAL

0.25% bupivacaine 20 ml with 3 mg morphine in TAP block

Combination Product: bupivacaine and morphine

Interventions

bupivacaine and morphine COMBINATION_PRODUCT

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.

Bupivacaine group; Bupivacaine morphine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to III Elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Purna kala Gurung

Dharān, Province No. 1, 56700, Nepal

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Purna k Gurung, MS

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Anaesthetic technician will prepare the study drug * Anaesthesiologist who is blind to the study drug will perform UG TAP block and collect data intra and post-operatively. * Patient will also be blind about the drug administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ( Assistant Professor)

Model Details: After obtaining written informed consent from a total of 40 patients fulfilling inclusion criteria will be enrolled. A 40 envelopes with number indicating the sequence of the patient on the outside and the allocated group and study drug inside will be made by an anaesthesiologist. An anaesthetic technician will prepare the study drug. The participants, clinicians and the investigator who is involved in patient assessment and collecting data postoperatively will be blinded. The study groups received the following study medication Group B - 0.25% bupivacaine 20 ml in TAP block Group BM - 0.25% bupivacaine 20 ml with 3 mg morphine in TAP block

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: August 18, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)