TAP Block and Subacute Pain in Inguinal Herniography

February 25, 2019 updated by: Dr Cigdem Akyol Beyoğlu, Istanbul University

Evaluation of the Effects of Subcostal Transversus Abdominis Plane Block on Subacute Pain Development Following Inguinal Herniography: a Randomized Clinical Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were divided into two groups, one is control and the second is subcostal transversus abdominis plane block (STAP) group. After standard general anesthesia application, control group ( Group I) had 1 gram of paracetamol and 100 mg of contramal just after starting surgical closure. Group II (STAP) had 1 gram of paracetamol and 100 mg of contramal, after surgical closure transversus abdominis plane block in subcostal area was applied to the patient.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients who have allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tramadol and paracetamol
subjects were administered intravenous analgesia (control group) Tramadol 100 mg and paracetamol 1000 mg at the end of the surgery
Drug: Tramadol and paracetamol
Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery
Other Names:
  • contramal
  • parol infusion solution
ACTIVE_COMPARATOR: transversus abdominis plane block
patients that applied transversus abdominis plane block at the end of the surgery after given intravenous analgesia
Drug: Tramadol and paracetamol
Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery
Other Names:
  • contramal
  • parol infusion solution
Procedure: transversus abdominis plane block
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.
Other Names:
  • stimuplex A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
verbal numeric scale
Time Frame: 1 month after the operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
verbal numeric scale
Time Frame: 15 minutes, 1-6-12-24 hours and 15 days after operation
according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain
15 minutes, 1-6-12-24 hours and 15 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (ESTIMATE)

September 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 235901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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