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

Pain, Postoperative Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056675
• Other study ID #: 2021-01792
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Hôpital Fribourgeois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 30, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• PENG block
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.
• Placebo
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.

Locations

Country	Name	City	State
Switzerland	HFR Fribourg - Hôpital cantonal	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Fribourgeois

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

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. — View 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. — View Citation

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total morphine consumption (morphine equivalent dose)	Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.	Total consumption of postoperative morphine in the first 24 hours after surgery
Secondary	Length of stay (days)	The length of hospital stay is measured in days, from the day of surgery (day 0) to the patient's discharge from the hospital. Discharge occurs up to a maximum of 7 days after surgery when the 3 following criteria are met: the scar must be dry, the pain must no longer require morphine and the patient must be able to walk with crutches	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