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

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ClinicalTrials.gov Identifier: NCT04650100
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: ultrasound-guided PENG bloc realized before surgery Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: PENG group
For the PENG group, the ultrasound-guided PENG block (20 ml of Ropivacaine 4.75 mg/ml) is performed before the surgery.
 Procedure: ultrasound-guided PENG bloc realized before surgery
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.
No Intervention: Control group
No additional intervention, only standard care


Outcome Measures
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Primary Outcome Measures :
  1. Cumulated postoperative morphine consumption 24 hours after surgery [ Time Frame: 24 hours ]
    calcul of Cumulated postoperative morphine consumption 24 hours after surgery


Secondary Outcome Measures :
  1. Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU) [ Time Frame: Hour 1 ]
    Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)

  2. Cumulated postoperative morphine consumption 48 hours after surgery [ Time Frame: Hour 48 ]
    Cumulated postoperative morphine consumption 48 hours after surgery

  3. Evaluation of pain in the PACU [ Time Frame: Hour 1 ]
    Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) in the PACU

  4. Evaluation of pain 24 hours after surgery [ Time Frame: Hour 24 ]
    Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 24 hours after surgery

  5. Evaluation of pain 48 hours after surgery [ Time Frame: Hour 48 ]
    Evaluation of pain using a simple numeric rating scale (NRS from 0 to 10) 48 hours after surgery

  6. Evaluation of the pain potentially induced by the realization of the PENG block [ Time Frame: Hour 0 ]
    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

  7. Evaluation of adverse effects associated with the PENG block [ Time Frame: Hour 0 ]
    Evaluation of adverse effects associated with the PENG block

  8. Evaluation of adverse effects associated with the PENG block [ Time Frame: Hour 1 ]
    Evaluation of adverse effects associated with the PENG block

  9. Evaluation of adverse effects associated with the PENG block [ Time Frame: Hour 24 ]
    Evaluation of adverse effects associated with the PENG block

  10. Evaluation of adverse effects associated with the PENG block [ Time Frame: Hour 48 ]
    Evaluation of adverse effects associated with the PENG block

  11. Evaluation of adverse effects associated with the use of morphine [ Time Frame: Hour 0 ]
    Evaluation of adverse effects associated with the use of morphine

  12. Evaluation of adverse effects associated with the use of morphine [ Time Frame: Hour 1 ]
    Evaluation of adverse effects associated with the use of morphine

  13. Evaluation of adverse effects associated with the use of morphine [ Time Frame: Hour 24 ]
    Evaluation of adverse effects associated with the use of morphine

  14. Evaluation of adverse effects associated with the use of morphine [ Time Frame: Hour 48 ]
    Evaluation of adverse effects associated with the use of morphine

  15. Evaluation of the patients' satisfaction [ Time Frame: Hour 24 ]
    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

  16. Evaluation of the adductor muscles weakness [ Time Frame: Hour 24 ]
    Evaluation of the adductor muscles weakness by a thigh adduction test performed 24 hours after surgery

  17. Evaluation of the quadricipital muscles weakness [ Time Frame: Hour 24 ]
    Evaluation of the quadricipital muscles weakness by a Timed to Up and Go Test performed 24 hours after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650100


Contacts
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Contact: FERRE Fabrice, PH 0561779988 ext +33 ferre.f@chu-toulouse.fr

Locations
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France
University Hospital of Toulouse Recruiting
Toulouse, France
Contact: Fabrice FERRE, PH    0561779988 ext +33    ferre.f@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: FERRE Fabrice, PH University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04650100    
Other Study ID Numbers: RC31/20/0227
2020-A01887-32 ( Other Identifier: ID-RCB )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Total hip arthroplasty
PENG bloc
local anaesthetics infiltration
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations