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NCT Number: NCT05379374

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purna kala Gurung

Dharān, Province No. 1, 56700, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. • 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

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

    Time frame: Till 24 hour after surgery

    Group with higher NRS score is considered a less effective Group with increase side effects is considered as not acceptable

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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