Effectiveness of PENG Block Combined to LFCN Block on the Quality of Recovery After Total Hip Replacement

NCT04245280 | Completed

• 1 other identifier: 19.275
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the effectiveness of the association of PENG and LFCN blocks on the quality of recovery 24 hours after total hip replacement surgery.

Conditions

Total Hip Replacement Surgery; Postoperative Pain

Keywords

Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Quality of recovery, QoR15 (Quality of Recovery 15)

  QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).

  Change between baseline (day 0) and post-operative day 1

Secondary Outcomes (8)

• Verbal numeric rating scale (vNRS) for pain assessment

  8 hours, 16 hours and 24 hours after the surgery

• Difficulty of realization of the block

  At the end of the blocks on Day 0

• Mild cognitive impairment assessment using the Montreal Cognitive Assessment (MoCA)

  Pre-operative day 0 (day before or morning of the surgery) and Post-operative day 1

• Opioids side effects

  8 hours, 16 hours and 24 hours after the surgery

• Quadriceps weakness

  On post-operative day 1

Study Arms (2)

PENG and LFCN blocks with ropivacaine

ACTIVE COMPARATOR

For the PENG block, and after negative aspiration, 20 ml of a solution of ropivacaine 0.5% with epinephrine 2.5 mcg/ml will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle.

Drug: Ropivacaine 0.5% Injectable Solution

PENG and LFCN blocks with saline solution

PLACEBO COMPARATOR

For the PENG block, and after negative aspiration, 20 ml of a saline solution will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same saline solution will be injected with the same needle.

Drug: Saline Solution

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

ropivacaine 0.5% with epinephrine 2.5 mcg/ml

Also known as: Ropivacaine 0.5%

PENG and LFCN blocks with ropivacaine

Saline Solution DRUG

normal saline solution (NaCl 0.9%)

Also known as: Placebo

PENG and LFCN blocks with saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old undergoing a total hip replacement surgery

You may not qualify if:

• Contraindication to regional anesthesia (allergy to local anesthetics, severe coagulopathy, infection in the designated area, pre-existing neuropathy in the obturator or femoral territory)
• Contraindication to spinal anesthesia
• Patient's refusal or inability to consent
• Opioid use on a regular basis pre-operatively
• Inability to communicate with medical team or research team
• Inability to understand the items of the multiple forms

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sébastien Garneau, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled, triple blind

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 28, 2020
• Study Start: May 4, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)