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

NCT05549492 | Completed Phase 1 DMC

• 1 other identifier: Nirvana Ahmed 01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Inguinal Hernia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain

  The 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)

  2 hours after the operation upto 48-hour analgesic after surgery

Study Arms (2)

Group B

EXPERIMENTAL

Candidates received 20 ml of 0.25% ropivacaine for TAP block

Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Group RB

EXPERIMENTAL

Candidates received 20 ml of 0.25% ropivacaine and 300 μg of buprenorphine, respectively, for the TAP block.

Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Interventions

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution DRUG

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.

Also known as: buprenorphine 300 μg

Group B; Group RB

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Inguinal Hernia
• Medically free

You may not qualify if:

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

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

October 6 University Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Ropivacaine; Buprenorphine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nirvana Elshalakany, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 30, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

EG (1)