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

Sponsor

B.P. Koirala Institute of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05379374

Collaborator

(none)

Enrollment

Location

Arms

17.1

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Combination Product: bupivacaine and morphine	N/A

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

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 blockAfter 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 (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.

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Aug 18, 2018

Actual Primary Completion Date :

Jan 20, 2020

Actual Study Completion Date :

Jan 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine group 0.25% bupivacaine 20 ml in TAP block	Combination Product: 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.
Experimental: Bupivacaine morphine group 0.25% bupivacaine 20 ml with 3 mg morphine in TAP block	Combination Product: 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.

Arm

Intervention/Treatment

Active Comparator: Bupivacaine group

0.25% bupivacaine 20 ml in TAP block

Combination Product: 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.

Experimental: Bupivacaine morphine group

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

Combination Product: 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.

Outcome Measures

Primary Outcome Measures

• Duration of postoperative analgesia • Postoperative analgesic requirement [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purna kala Gurung	Dharān Bāzār	Province No. 1	Nepal	56700

Sponsors and Collaborators

B.P. Koirala Institute of Health Sciences

Investigators

Principal Investigator: Purna k Gurung, MS, B.P. Koirala Institute of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Purna Kala Gurung, Principal Investigator ( Assistant Professor), B.P. Koirala Institute of Health Sciences

ClinicalTrials.gov Identifier:

NCT05379374

Other Study ID Numbers:

IRC/1182/017

First Posted:

May 18, 2022

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Purna Kala Gurung, Principal Investigator ( Assistant Professor), B.P. Koirala Institute of Health Sciences

TAP block,

Morphine,

Inguinal hernia

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022