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Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery

Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05549492
Enrollment
64
Registered
2022-09-22
Start date
2021-01-01
Completion date
2022-05-30
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Pain, Postoperative

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

Interventions

The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means no pain and 10 means the worst pain as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present.

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

to determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repaired

Eligibility

Sex/Gender
ALL
Age
30 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Pain2 hours after the operation upto 48-hour analgesic after surgeryThe pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026