Clinical trial NCT05379374: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: TAP block,
Morphine,
Inguinal hernia
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 block
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: • Duration of postoperative analgesia • Postoperative analgesic requirement
timeFrame: Till 24 hour after surgery
Secondary outcomes:
measure: • NRS for pain at rest and on cough between the groups • Any side effects
timeFrame: Till 24 hour after surgery
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: Purna kala Gurung
state: Province No. 1
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences
name: Purna k Gurung, MS
role: PRINCIPAL_INVESTIGATOR
References: