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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Combination Product: bupivacaine and morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine group<br>0.25% bupivacaine 20 ml in TAP block | Combination Product: bupivacaine and morphine<br>* 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.<br>|
| Experimental: Bupivacaine morphine group<br>0.25% bupivacaine 20 ml with 3 mg morphine in TAP block | Combination Product: bupivacaine and morphine<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block,, Morphine,, Inguinal hernia