Clinical trial NCT05056675: The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.
Official title: The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay: A Multidisciplinary Prospective Randomized Double-blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: PENG block
Postoperative pain
Elective hip surgery
Total hip arthroplasty
Surgical hip dislocation
Lead sponsor: Hôpital Fribourgeois
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).
Primary purpose: TREATMENT

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.

Detailed description: Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.

This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Reduction of postoperative pain in the first 24 hours after surgery
Secondary outcomes:
measure: Total morphine consumption (morphine equivalent dose)
timeFrame: Total consumption of postoperative morphine in the first 24 hours after surgery
measure: Length of stay (days)
timeFrame: 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
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital cantonal
Study officials:
affiliation: HFR Fribourg - Hôpital cantonal
name: Matthieu Hanauer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
citation: 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.
citation: 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.