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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379374
• Other study ID #: IRC/1182/017
• Status: Completed
• Phase: N/A
• Start date: August 18, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: May 2022
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.

Locations

Country	Name	City	State
Nepal	Purna kala Gurung	Dharan Bazar	Province No. 1

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	• 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