Clinical trial NCT04295408: Pericapsular Nerve Group Block for Total Hip Arthroplasty
Official title: Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Postoperative Pain
Keywords: hip arthoplasty
nerve block
analgesia
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.

Detailed description: The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty.

it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia.

Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups:

* PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline.
* Placebo group (SG) who received 40 ml of saline.

Postoperative analgesia started before extubation of the patient, with:

* IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days.
* non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days.
* Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.

Eligibility criteria: Inclusion Criteria:

* primary THA with lateral approach under general anesthesia.

Exclusion Criteria:

* Hip fracture,
* allergy to local anesthetics,
* peripheral neuropathy,
* creatinin clearance inferior to 30ml/min,
* weight inferior to 50 Kg or superior to 100 Kg,
* neurological disorder affecting the lower extremity, significant psychiatric conditions,
* patients receiving corticosteroid therapy,
* chronic consumption of opioids (\>2 months).

Primary outcomes:
measure: Total morphine consumption
timeFrame: day one
Secondary outcomes:
measure: intraoperative opioid consumption
timeFrame: Day 0
measure: Pain score after extubation
timeFrame: up to 30 minutes
measure: postoperative pain score
timeFrame: day one
measure: Pain score during seating position
timeFrame: day one
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Institut Kassab D'Orthopedie
Study officials:
affiliation: Tunis El Manar University
name: khaireddine Raddaoui, MD
role: PRINCIPAL_INVESTIGATOR
References: