Analgesia, Inguinal Hernia, Pain, Acute, Pain, Chronic, Pain, Neuropathic
Conditions
Keywords
transversus abdominis plane block, dexmedetomidine
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.
Interventions
OTHERlocal anesthetic and 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
OTHERlocal anesthetic and placebo
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
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score 6 hours postoperatively | 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 |
| pain score 3 hours postoperatively | 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 |
| pain score 24 hours postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of chronic pain | 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
| Measure | Time frame | Description |
|---|---|---|
| morphine consumption | 24 hours postoperatively | morphine consumption through patient-controlled analgesia device for 24 hours postoperatively |
| transversus abdominis plane-related complications | 48 hours postoperatively | transversus abdominis plane-related complications at the site of the local anesthetic injection |
| satisfaction from postoperative analgesia | 24 hours postoperatively | satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction |
Countries
Greece
Outcome results
None listed