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NCT Number: NCT04403711

Dexmedetomidine in TAP Block for 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

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Key information

Conditions

Inguinal Hernia Acute Pain Agnosia Analgesia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pain, Acute Pain, Chronic Pain, Neuropathic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, Attica, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local anesthetic and dexmedetomidine

Other

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

local anesthetic and placebo

Other

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

Primary outcomes

  1. 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"

  2. 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"

  3. 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"

Secondary outcomes

  1. 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

Other outcomes

  1. morphine consumption

    Time frame: 24 hours postoperatively

    morphine consumption through patient-controlled analgesia device for 24 hours postoperatively

  2. 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

  3. transversus abdominis plane-related complications

    Time frame: 48 hours postoperatively

    transversus abdominis plane-related complications at the site of the local anesthetic injection

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Acronym: TAP-dex

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 27, 2020
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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