The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

NCT05056675 | Completed

• 1 other identifier: 2021-01792
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries. As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.

Conditions

Pain, Postoperative

Keywords

PENG block; Postoperative pain; Elective hip surgery; Total hip arthroplasty; Surgical hip dislocation

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity

  Reduction of postoperative pain in the first 24 hours after surgery

Secondary Outcomes (2)

• Total morphine consumption (morphine equivalent dose)

  Total consumption of postoperative morphine in the first 24 hours after surgery

• Length of stay (days)

  Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative days

Study Arms (2)

PENG block for anterior total hip arthroplasty or surgical hip dislocation

EXPERIMENTAL

All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of 0.5% ropivacaine iv is injected.

Procedure: PENG block

Placebo for anterior total hip arthroplasty or surgical hip dislocation

PLACEBO COMPARATOR

All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of NaCL 0.9% is injected.

Procedure: Placebo

Interventions

PENG block PROCEDURE

All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected.

PENG block for anterior total hip arthroplasty or surgical hip dislocation

Placebo PROCEDURE

ll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected.

Placebo for anterior total hip arthroplasty or surgical hip dislocation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior total hip arthroplasty for hip osteoarthritis
• Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
• Age 16-85 years
• American Society of Anesthesiologists (ASA) physical status 1 to 3

You may not qualify if:

• Patient refusal/no informed consent
• Inability to give informed consent
• Lateral approach for total hip arthroplasty
• Bilateral procedure
• Additional osteotomies of the femur and/or acetabulum
• Previous hip \& pelvis surgery
• Chronic opioid users
• Known allergy or intolerance to medications used in the trial (local anesthetic, opioid)
• Infection at the injection site
• Body mass index \> 40kg/m2
• Spinal anesthesia

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

Study Sites (1)

HFR Fribourg - Hôpital cantonal

Fribourg, 1700, Switzerland

Location

Related Publications (7)

• Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.

  PMID: 17964352 BACKGROUND

• Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.

  PMID: 9479711 BACKGROUND

• Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.

  PMID: 28494088 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.

  PMID: 30930716 BACKGROUND

• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

  PMID: 34196965 BACKGROUND

• Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668.

  PMID: 23338004 BACKGROUND

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

• Matthieu Hanauer, M.D.

  HFR Fribourg - Hôpital cantonal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending surgeon, M.D.

Model Details: Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).

Study Record Dates

• First Submitted: August 28, 2021
• First Posted: September 24, 2021
• Study Start: June 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: November 30, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The study will start in June 2022 and summary data will be published.
• Access Criteria: Publication in progress

Locations

CH (1)