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Clinical Trials/NCT05379374
NCT05379374CompletedNot Applicable

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

B.P. Koirala Institute of Health Sciences1 site in 1 country40 target enrollmentStarted: August 18, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
• Duration of postoperative analgesia • Postoperative analgesic requirement

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

  • 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.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Bupivacaine group

Active Comparator

0.25% bupivacaine 20 ml in TAP block

Intervention: bupivacaine and morphine (Combination Product)

Bupivacaine morphine group

Experimental

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

Intervention: bupivacaine and morphine (Combination Product)

Outcomes

Primary Outcomes

• Duration of postoperative analgesia • Postoperative analgesic requirement

Time Frame: Till 24 hour after surgery

Time from TAP block to first request of analgesic is considered as duration of analgesia Less requirement of rescue analgesic is considered as better

Secondary Outcomes

  • • NRS for pain at rest and on cough between the groups • Any side effects(Till 24 hour after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Purna Kala Gurung

Principal Investigator ( Assistant Professor)

B.P. Koirala Institute of Health Sciences

Study Sites (1)

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