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TAP Block and Subacute Pain in Inguinal Herniography

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ClinicalTrials.gov Identifier: NCT02914028
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Cigdem Akyol Beyoğlu, Istanbul University

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


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: transversus abdominis plane block Drug: Tramadol and paracetamol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of Subcostal Transversus Abdominis Plane Block on Subacute Pain Development Following Inguinal Herniography: a Randomized Clinical Study
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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
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 Name: stimuplex A

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Dr Cigdem Akyol Beyoğlu, medical doctor, Istanbul University
ClinicalTrials.gov Identifier: NCT02914028    
Other Study ID Numbers: 235901
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Cigdem Akyol Beyoğlu, Istanbul University:
TAP block
subacute pain
inguinal herniography
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants