TAP Block and Subacute Pain in Inguinal Herniography

NCT02914028 | Completed

• 1 other identifier: 235901
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain. Transversus abdominis plane block is a current intervention to support postoperative analgesia, however it is recently in research area how to be applied in different surgical areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane block is not advised but has not been studied to be effective for postoperative analgesia in inguinal herniography patients. This study aims to research the effect of subcostal transversus abdominis plane block in subacute postoperative pain after inguinal hernia repair

Conditions

Postoperative Pain

Keywords

TAP block; subacute pain; inguinal herniography

Outcome Measures

Primary Outcomes (1)

• verbal numeric scale

  patients were questioned for pain graduation to give a point from 0 to 10 according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain

  1 month after the operation

Secondary Outcomes (1)

• verbal numeric scale

  15 minutes, 1-6-12-24 hours and 15 days after operation

Study Arms (2)

Tramadol and paracetamol

ACTIVE COMPARATOR

subjects were administered intravenous analgesia (control group) Tramadol 100 mg and paracetamol 1000 mg at the end of the surgery

Drug: Tramadol and paracetamol

transversus abdominis plane block

ACTIVE COMPARATOR

patients that applied transversus abdominis plane block at the end of the surgery after given intravenous analgesia

Procedure: transversus abdominis plane block; Drug: Tramadol and paracetamol

Interventions

transversus abdominis plane block PROCEDURE

A peripheric block needle is inserted entering the facia between musculus rectus abdominis and musculus transversus abdominis with ultrasonography and local anesthetics are injected in the facia.

Also known as: stimuplex A

transversus abdominis plane block

Tramadol and paracetamol DRUG

Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery

Also known as: contramal, parol infusion solution

Tramadol and paracetamol; transversus abdominis plane block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• who were to undergo elective unilateral inguinal herniography with "mesh" under general anesthesia.

You may not qualify if:

• patients who have allergy to local anesthetics

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultracet; Tramadol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 26, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share