Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
bupivacaine and morphine
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring TAP block,, Morphine,, Inguinal hernia
Eligibility Criteria
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
Sites / Locations
- Purna kala Gurung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine group
Bupivacaine morphine group
Arm Description
0.25% bupivacaine 20 ml in TAP block
0.25% bupivacaine 20 ml with 3 mg morphine in TAP block
Outcomes
Primary Outcome Measures
• 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
Secondary Outcome Measures
• 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
Full Information
NCT ID
NCT05379374
First Posted
May 13, 2022
Last Updated
May 17, 2022
Sponsor
B.P. Koirala Institute of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05379374
Brief Title
Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2018 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
TAP block,, Morphine,, Inguinal hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
0.25% bupivacaine 20 ml in TAP block
Arm Title
Bupivacaine morphine group
Arm Type
Experimental
Arm Description
0.25% bupivacaine 20 ml with 3 mg morphine in TAP block
Intervention Type
Combination Product
Intervention Name(s)
bupivacaine and morphine
Intervention Description
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 Outcome Measure Information:
Title
• Duration of postoperative analgesia • Postoperative analgesic requirement
Description
Time from TAP block to first request of analgesic is considered as duration of analgesia Less requirement of rescue analgesic is considered as better
Time Frame
Till 24 hour after surgery
Secondary Outcome Measure Information:
Title
• NRS for pain at rest and on cough between the groups • Any side effects
Description
Group with higher NRS score is considered a less effective Group with increase side effects is considered as not acceptable
Time Frame
Till 24 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Purna k Gurung, MS
Organizational Affiliation
B.P. Koirala Institute of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purna kala Gurung
City
Dharān Bāzār
State/Province
Province No. 1
ZIP/Postal Code
56700
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair
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