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

Aretaieion University Hospital

Status: Enrolling

Conditions: Pain, Acute; Pain, Chronic; Pain, Neuropathic; Analgesia; Inguinal Hernia

Treatments: Other: local anesthetic and dexmedetomidine; Other: local anesthetic and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04403711

TAP-dexmedetomidine

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

local anesthetic and dexmedetomidine

Active Comparator group

Description:

ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL dexmedetomidine

Treatment:

Other: local anesthetic and dexmedetomidine

local anesthetic and placebo

Placebo Comparator group

Description:

ultrasound-guided transversus abdominis plane block with 25 mL ropivacaine 0.5% and 2 mL normal saline

Treatment:

Other: local anesthetic and placebo