Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery

NCT04650100 | Completed

• 2 other identifiers: RC31/20/02272020-A01887-32
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. Regional anaesthesia (RA) like the recently described pericapsular nerve group (PENG) block could provide additional analgesic benefit in this setting. Investigators main objective is to demonstrate the analgesic benefits (postoperative pain score and morphine consumption) of the PENG block when added to intra- and peri-articular infiltration of local anaesthetic following total hip arthroplasty. Investigators make the assumption that i) the PENG bloc could reduce the postoperative 24 first hours morphine consumption by 30%, ii) the PENG block could spare the motor function of the quadriceps and adductor muscles, and iii) the PENG bloc could be well tolerated allowing a high level of patient satisfaction.

Conditions

Postoperative Pain

Keywords

Total hip arthroplasty; PENG bloc; local anaesthetics infiltration; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Cumulated postoperative morphine consumption 24 hours after surgery

  calcul of Cumulated postoperative morphine consumption 24 hours after surgery

  24 hours

Secondary Outcomes (17)

• Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)

  Hour 1

• Cumulated postoperative morphine consumption 48 hours after surgery

  Hour 48

• Evaluation of pain in the PACU

  Hour 1

• Evaluation of pain 24 hours after surgery

  Hour 24

• Evaluation of pain 48 hours after surgery

  Hour 48

Study Arms (2)

PENG group

EXPERIMENTAL

For the PENG group, the ultrasound-guided PENG block (20 ml of Ropivacaine 4.75 mg/ml) is performed before the surgery.

Procedure: ultrasound-guided PENG bloc realized before surgery

Control group

NO INTERVENTION

No additional intervention, only standard care

Interventions

ultrasound-guided PENG bloc realized before surgery PROCEDURE

ultrasound-guided PENG block realized before surgery. The PENG block, described by Giron-Arebgi is made in the supine position. The ultrasound probe used is a 5 MHz high frequency linear probe placed parallel to the line delimited by the anterior-inferior iliac spine (lateral) and the pubis (medial). The needle used is an 80 mm, 22G, needle inserted in the ultrasound plane. The slow and fractioned injection of 20 ml of Ropivacaine 4.75 mg/ml is performed in the fascia between the psoas tendon and the iliopubic eminence under ultrasound guidance.

PENG group

Eligibility Criteria

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

You may qualify if:

• Scheduled for total hip arthroplasty surgery under general anaesthesia
• Affiliated of a social security scheme
• Having signed the written informed consent

You may not qualify if:

• Total hip arthroplasty revision surgery
• Refusal of the patient to participate
• Existence of major spontaneous or acquired haemostasis disorders
• Infection at the puncture site
• Allergy to local anaesthetics
• Pregnancy or breast-feeding
• Patients under the protection of adults (guardianship, curatorship or protection of justice)
• Patients whose cognitive state does not allow assessment by the scales used.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Related Publications (1)

• Ferre F, Rey J, Bosch L, Menut R, Ferrier A, Ba C, Halimi C, Collinson I, Tissot B, Labaste F, Reina N, Minville V. Pericapsular nerve group (PENG) block combined with local infiltration analgesia is not superior to local infiltration analgesia for the management of postoperative pain after primary elective total hip arthroplasty: A prospective, randomized, controlled, single-blind trial. Heliyon. 2024 Jun 27;10(13):e33766. doi: 10.1016/j.heliyon.2024.e33766. eCollection 2024 Jul 15.

  PMID: 39071707 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• FERRE Fabrice, PH

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: December 14, 2020
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: November 28, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)