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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PENG block
Placebo
Sponsored by
Hôpital Fribourgeois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring PENG block, Postoperative pain, Elective hip surgery, Total hip arthroplasty, Surgical hip dislocation

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HFR Fribourg - Hôpital cantonal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PENG block for anterior total hip arthroplasty or surgical hip dislocation

Placebo for anterior total hip arthroplasty or surgical hip dislocation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total morphine consumption (morphine equivalent dose)
Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.
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

Full Information

First Posted
August 28, 2021
Last Updated
September 23, 2021
Sponsor
Hôpital Fribourgeois
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1. Study Identification

Unique Protocol Identification Number
NCT05056675
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Fribourgeois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
PENG block, Postoperative pain, Elective hip surgery, Total hip arthroplasty, Surgical hip dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG block for anterior total hip arthroplasty or surgical hip dislocation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo for anterior total hip arthroplasty or surgical hip dislocation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PENG block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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
Time Frame
Reduction of postoperative pain in the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Total morphine consumption (morphine equivalent dose)
Description
Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.
Time Frame
Total consumption of postoperative morphine in the first 24 hours after surgery
Title
Length of stay (days)
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Hanauer, M.D.
Phone
+41263062810
Email
matthieu.hanauer@h-fr.ch
Facility Information:
Facility Name
HFR Fribourg - Hôpital cantonal
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD and results of this study will be presented at national and international orthopedic meetings and will be submitted to highly-ranked peer reviewed orthopedic journals.
IPD Sharing Time Frame
The study will start in January 2022 and summary data will be published.
Citations:
PubMed Identifier
17964352
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.
Results Reference
background
PubMed Identifier
9479711
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.
Results Reference
background
PubMed Identifier
28494088
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.
Results Reference
background
PubMed Identifier
30063657
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.
Results Reference
background
PubMed Identifier
30930716
Citation
Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
Results Reference
background
PubMed Identifier
34196965
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.
Results Reference
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PubMed Identifier
23338004
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.
Results Reference
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The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

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