Clinical trial NCT04403711: Dexmedetomidine in TAP Block for Inguinal Hernia Repair
Official title: The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Analgesia
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Keywords: transversus abdominis plane block
dexmedetomidine
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain score 3 hours postoperatively
timeFrame: 3 hours after surgery
measure: pain score 6 hours postoperatively
timeFrame: 6 hours after surgery
measure: pain score 24 hours postoperatively
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: incidence of chronic pain
timeFrame: 6 months after surgery
Other outcomes:
measure: morphine consumption
timeFrame: 24 hours postoperatively
measure: satisfaction from postoperative analgesia
timeFrame: 24 hours postoperatively
measure: transversus abdominis plane-related complications
timeFrame: 48 hours postoperatively
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
state: Αττική
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
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