Pericapsular Nerve Group Block for Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Postoperative Pain; Hip Arthropathy
• Interventions: Procedure: Pericapsular nerve group block with ropivacaine; Procedure: Pericapsular nerve group block with saline solution

• Registration Number: NCT04295408
• Lead Sponsor: University Tunis El Manar

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.

Study Timeline

• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Study Start: 2020-04-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pericapsular nerve group block	Pericapsular nerve group block with ropivacaine	Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline
PLACEBO	Pericapsular nerve group block with saline solution	Pericapsular Nerve Group block with 40 ml saline

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	day one	morphine consumption on mg

Secondary Outcome Measures

Name	Time	Method
Pain score after extubation	up to 30 minutes	simplified numerical score (SNS) after extubation \[0=no pain , 10=worst pain\].
intraoperative opioid consumption	Day 0	total intraoperative fentanyl consumption on microg
postoperative pain score	day one	simplified numerical score (SNS) \[0=no pain , 10=worst pain\].
Pain score during seating position	day one	simplified numerical score (SNS) during seating position \[0=no pain , 10=worst pain\].

Trial Locations

Locations (1)

Institut Kassab D'Orthopedie; 🇹🇳 Tunis, Tunisia