Clinical trial NCT05549492: Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Official title: Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inguinal Hernia
Pain, Postoperative
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: to determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repaired
Primary purpose: TREATMENT

Brief summary: Buprenorphine intravenous, sublingual, and transdermal patches have been researched for their antihyperalgesic effects, although peripherally mediated effects have not been examined in Egypt surprisingly

Detailed description: This prospective, randomized, double-blind controlled trial involved 88 patients who were scheduled for inguinal hernia surgery followed by a TAP block. Patients were allocated into group B (n= 44) received 20 ml of 0.25% Ropivacaine for TAP block; group BR (n= 44) received 20 ml of 0.25% Ropivacaine containing 300 μg of buprenorphine for TAP Block. The primary outcome of the study was the analgesic and antihyperalgesic effect of buprenorphine compared to the control group. The duration of analgesia, analgesic consumption, postoperative pain scores at rest and sitting up to 48 hrs, and effect on wound hyperalgesia at 24 and 48 hrs were evaluated. Secondary outcomes of the study include incidence of side effects and TAP block-related complications were recorded. Effect of buprenorphine on patients with predicted high pain scores and incidence of persistent postoperative pain were also determined.

A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

Eligibility criteria: Inclusion Criteria:

1. Patients with Inguinal Hernia
2. Medically free

Exclusion Criteria:

1. participants with a history of heart, renal and liver cell failure.
2. allergic reaction to studied drugs, and history of epilepsy,
3. hydrodynamic instability,
4. chronic pain.
5. mental illness.

Primary outcomes:
measure: Post Operative Pain
timeFrame: 2 hours after the operation upto 48-hour analgesic after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University Hospital
Study officials:
affiliation: Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
name: Nirvana Elshalakany, Professor
role: PRINCIPAL_INVESTIGATOR
References: