Dexmedetomidine in TAP Block for Inguinal Hernia Repair (TAP-dex)

July 10, 2022 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair

This prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia

Study Overview

Detailed Description

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. It can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the Lichtenstein technique under general anesthesia.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Αττική
      • Athens, Αττική, Greece, 11528
        • Recruiting
        • ARETAIEION University Hospital
        • Contact:
          • Ioannis Koutalas, MD

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
  • open hernia repair
  • elective surgery

Exclusion Criteria:

  • inability to consent to the study due to language barriers or cognitive dysfunction -
  • bilateral inguinal hernia repair,
  • body mass index over 40 kg m-2,
  • skin infection at the puncture site
  • contraindication to paracetamol or non-steroidal anti-inflammatory drug (NSAIDs) administration
  • known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
  • coagulation abnormalities
  • history of gastroesophageal reflux and preoperative use of opioids or NSAIDs for chronic pain conditions
  • reoperation of recurrent inguinal hernia after previous mesh repair

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: local anesthetic and dexmedetomidine
ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine
in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine
Other Names:
  • medication used in regional anesthetic technique
Placebo Comparator: local anesthetic and placebo
ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline
in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline
Other Names:
  • medication used in regional anesthetic technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score 6 hours postoperatively
Time Frame: 6 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
6 hours after surgery
pain score 24 hours postoperatively
Time Frame: 24 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
24 hours after surgery
pain score 3 hours postoperatively
Time Frame: 3 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
3 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of chronic pain
Time Frame: 6 months after surgery
occurrence of chronic pain at the site of the operation, with the use of the NRS, at rest and during movement
6 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction from postoperative analgesia
Time Frame: 24 hours postoperatively
satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
24 hours postoperatively
morphine consumption
Time Frame: 24 hours postoperatively
morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
24 hours postoperatively
transversus abdominis plane-related complications
Time Frame: 48 hours postoperatively
transversus abdominis plane-related complications at the site of the local anesthetic injection
48 hours postoperatively

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

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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