Clinical trial NCT04650100: Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
Official title: Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Total hip arthroplasty
PENG bloc
local anaesthetics infiltration
postoperative pain
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Cumulated postoperative morphine consumption 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulated postoperative morphine consumption in the post anaesthesia care unit (PACU)
timeFrame: Hour 1
measure: Cumulated postoperative morphine consumption 48 hours after surgery
timeFrame: Hour 48
measure: Evaluation of pain in the PACU
timeFrame: Hour 1
measure: Evaluation of pain 24 hours after surgery
timeFrame: Hour 24
measure: Evaluation of pain 48 hours after surgery
timeFrame: Hour 48
measure: Evaluation of the pain potentially induced by the realization of the PENG block
timeFrame: Hour 0
measure: Evaluation of adverse effects associated with the PENG block
timeFrame: Hour 0
measure: Evaluation of adverse effects associated with the PENG block
timeFrame: Hour 1
measure: Evaluation of adverse effects associated with the PENG block
timeFrame: Hour 24
measure: Evaluation of adverse effects associated with the PENG block
timeFrame: Hour 48
measure: Evaluation of adverse effects associated with the use of morphine
timeFrame: Hour 0
measure: Evaluation of adverse effects associated with the use of morphine
timeFrame: Hour 1
measure: Evaluation of adverse effects associated with the use of morphine
timeFrame: Hour 24
measure: Evaluation of adverse effects associated with the use of morphine
timeFrame: Hour 48
measure: Evaluation of the patients' satisfaction
timeFrame: Hour 24
measure: Evaluation of the adductor muscles weakness
timeFrame: Hour 24
measure: Evaluation of the quadricipital muscles weakness
timeFrame: Hour 24
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: FERRE Fabrice, PH
role: PRINCIPAL_INVESTIGATOR
References: