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Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery (THAPeng)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound-guided PENG bloc realized before surgery
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Total hip arthroplasty, PENG bloc, local anaesthetics infiltration, postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PENG group

Control group

Arm Description

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

No additional intervention, only standard care

Outcomes

Primary Outcome Measures

Cumulated postoperative morphine consumption 24 hours after surgery
calcul of Cumulated postoperative morphine consumption 24 hours after surgery

Secondary Outcome Measures

Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Cumulated postoperative morphine consumption 48 hours after surgery
Cumulated postoperative morphine consumption 48 hours after surgery
Evaluation of pain in the PACU
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) in the PACU
Evaluation of pain 24 hours after surgery
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 24 hours after surgery
Evaluation of pain 48 hours after surgery
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 48 hours after surgery
Evaluation of the pain potentially induced by the realization of the PENG block
Evaluation of the pain potentially induced by the realization of the PENG block with Likert scale from 1 to 5, 1 is for no pain, 5 is for the worse pain
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the PENG block
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of adverse effects associated with the use of morphine
Evaluation of the patients' satisfaction
Evaluation of the patients' satisfaction by the EVAN-LR score realized 24 hours after surgery. EVAN-LR is a scale assessing perioperative patient's satisfaction with Loco Regional anaesthesia
Evaluation of the adductor muscles weakness
Evaluation of the adductor muscles weakness by a thigh adduction test performed 24 hours after surgery
Evaluation of the quadricipital muscles weakness
Evaluation of the quadricipital muscles weakness by a Timed to Up and Go Test performed 24 hours after surgery

Full Information

First Posted
November 24, 2020
Last Updated
October 13, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04650100
Brief Title
Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
Acronym
THAPeng
Official Title
Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

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
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.
Detailed Description
A recent study has revealed a region of pericapsular terminal branches of the femoral nerve and the obturator nerve accessible to ultrasound-guided regional anaesthesia. This technique, also called the PENG block, has recently been described with a substantial benefit on pain at rest and induced by mobilization in cases series of patients undergoing hip fracture surgery. To investigators knowledge, no randomized data concerning the analgesic efficacy of the PENG block has been published in the setting of elective total hip arthroplasty. The PENG block would allow a significant analgesic contribution when added to intra- and peri-articular infiltration of local anaesthetics while being well tolerated with few undesirable effects. Moreover, the PENG block could spare the motor function of the quadriceps and adductor muscles allowing enhanced recovery after surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Total hip arthroplasty, PENG bloc, local anaesthetics infiltration, postoperative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG group
Arm Type
Experimental
Arm Description
For the PENG group, the ultrasound-guided PENG block (20 ml of Ropivacaine 4.75 mg/ml) is performed before the surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No additional intervention, only standard care
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided PENG bloc realized before surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulated postoperative morphine consumption 24 hours after surgery
Description
calcul of Cumulated postoperative morphine consumption 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Description
Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
Time Frame
Hour 1
Title
Cumulated postoperative morphine consumption 48 hours after surgery
Description
Cumulated postoperative morphine consumption 48 hours after surgery
Time Frame
Hour 48
Title
Evaluation of pain in the PACU
Description
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) in the PACU
Time Frame
Hour 1
Title
Evaluation of pain 24 hours after surgery
Description
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 24 hours after surgery
Time Frame
Hour 24
Title
Evaluation of pain 48 hours after surgery
Description
Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 48 hours after surgery
Time Frame
Hour 48
Title
Evaluation of the pain potentially induced by the realization of the PENG block
Description
Evaluation of the pain potentially induced by the realization of the PENG block with Likert scale from 1 to 5, 1 is for no pain, 5 is for the worse pain
Time Frame
Hour 0
Title
Evaluation of adverse effects associated with the PENG block
Description
Evaluation of adverse effects associated with the PENG block
Time Frame
Hour 0
Title
Evaluation of adverse effects associated with the PENG block
Description
Evaluation of adverse effects associated with the PENG block
Time Frame
Hour 1
Title
Evaluation of adverse effects associated with the PENG block
Description
Evaluation of adverse effects associated with the PENG block
Time Frame
Hour 24
Title
Evaluation of adverse effects associated with the PENG block
Description
Evaluation of adverse effects associated with the PENG block
Time Frame
Hour 48
Title
Evaluation of adverse effects associated with the use of morphine
Description
Evaluation of adverse effects associated with the use of morphine
Time Frame
Hour 0
Title
Evaluation of adverse effects associated with the use of morphine
Description
Evaluation of adverse effects associated with the use of morphine
Time Frame
Hour 1
Title
Evaluation of adverse effects associated with the use of morphine
Description
Evaluation of adverse effects associated with the use of morphine
Time Frame
Hour 24
Title
Evaluation of adverse effects associated with the use of morphine
Description
Evaluation of adverse effects associated with the use of morphine
Time Frame
Hour 48
Title
Evaluation of the patients' satisfaction
Description
Evaluation of the patients' satisfaction by the EVAN-LR score realized 24 hours after surgery. EVAN-LR is a scale assessing perioperative patient's satisfaction with Loco Regional anaesthesia
Time Frame
Hour 24
Title
Evaluation of the adductor muscles weakness
Description
Evaluation of the adductor muscles weakness by a thigh adduction test performed 24 hours after surgery
Time Frame
Hour 24
Title
Evaluation of the quadricipital muscles weakness
Description
Evaluation of the quadricipital muscles weakness by a Timed to Up and Go Test performed 24 hours after surgery
Time Frame
Hour 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for total hip arthroplasty surgery under general anaesthesia Affiliated of a social security scheme Having signed the written informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERRE Fabrice, PH
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery

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