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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-18

Study Completion Date

2020-01-20

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.

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

* 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.

Study Groups

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Bupivacaine group

0.25% bupivacaine 20 ml in TAP block

Group Type ACTIVE_COMPARATOR

bupivacaine and morphine

Intervention Type 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 morphine group

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

Group Type EXPERIMENTAL

bupivacaine and morphine

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No