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Pericapsular Nerve Group Block for Total Hip Arthroplasty

Primary Purpose

Hip Arthropathy, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Pericapsular nerve group block with saline solution
Pericapsular nerve group block with ropivacaine
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy focused on measuring hip arthoplasty, nerve block, analgesia

Eligibility Criteria

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

Inclusion Criteria:

  • primary THA with lateral approach under general anesthesia.

Exclusion Criteria:

  • Hip fracture,
  • allergy to local anesthetics,
  • peripheral neuropathy,
  • creatinin clearance inferior to 30ml/min,
  • weight inferior to 50 Kg or superior to 100 Kg,
  • neurological disorder affecting the lower extremity, significant psychiatric conditions,
  • patients receiving corticosteroid therapy,
  • chronic consumption of opioids (>2 months).

Sites / Locations

  • Institut Kassab D'OrthopedieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

PLACEBO

Pericapsular nerve group block

Arm Description

Pericapsular Nerve Group block with 40 ml saline

Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline

Outcomes

Primary Outcome Measures

Total morphine consumption
morphine consumption on mg

Secondary Outcome Measures

intraoperative opioid consumption
total intraoperative fentanyl consumption on microg
Pain score after extubation
simplified numerical score (SNS) after extubation [0=no pain , 10=worst pain].
postoperative pain score
simplified numerical score (SNS) [0=no pain , 10=worst pain].
Pain score during seating position
simplified numerical score (SNS) during seating position [0=no pain , 10=worst pain].

Full Information

First Posted
February 23, 2020
Last Updated
June 16, 2020
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT04295408
Brief Title
Pericapsular Nerve Group Block for Total Hip Arthroplasty
Official Title
Efficacy of Pericapsular Nerve Group Block After Total Hip Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

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

5. Study Description

Brief Summary
Controlling pain after hip replacement surgery improves comfort and partient satisfaction. Pain after hip replacement has traditionally been managed using systemic pain medications including acetaminophen and non-steroidal anti-inflammatory drugs. A recent Cochrane review demonstrated that compared to systemic analgesia alone, peripheral nerve blocks reduce postoperative pain with moderate-quality evidence. Pericapsular Nerve Group block is a new technique allowing local anesthetic diffusion to femoral, obturator and accessory obturator nerves and providing a good analgesic effect for hip fracture surgery. Investigators hypothesized that the PENG block could be an interesting alternative to systemic analgesiscs for pain control after total hip replacement.
Detailed Description
The aim of the study was to evaluate the efficacy of the PENG block for intra and postoperative pain control in total hip arthroplasty. it was a monocentric, randomized, controlled and double blind study. Patients scheduled for primary THA with lateral approach under general anesthesia. Premedication with IV midazolam 1 to 2 mg on arrival to operating theatre. general anesthesia was conducted using fentanyl, propofol and cisatracurium for induction and isoflurane for maintanance patients were randomized using a random table in two groups: PENG Block group (PG) who received 2 mg.kg-1Ropivacaine in 40 ml of saline. Placebo group (SG) who received 40 ml of saline. Postoperative analgesia started before extubation of the patient, with: IV paracetamol 1g/6h in Day1 and oral paracetamol 1g/8h for 6 days. non steroidal anti inflammatory drugs with IM piroxicam 20 mg on day one (at the end of surgery) and oral diclofenac 50 mg/12h for 3 days. Morphine PCA for day 1 (24 H) and oral tramadol 50 mg/12h from day 2 to day 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy, Postoperative Pain
Keywords
hip arthoplasty, nerve block, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Pericapsular Nerve Group block with 40 ml saline
Arm Title
Pericapsular nerve group block
Arm Type
Experimental
Arm Description
Pericapsular Nerve Group block with 2 mg.kg-1Ropivacaine in 40 ml of saline
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block with saline solution
Intervention Description
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the saline solution was injected in 5-mL increments while observing for adequate fluid spread in this plane.a total volune of 40 ml saline solution was injected.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block with ropivacaine
Intervention Description
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, local anesthetic was injected in 5-mL increments while observing for adequate fluid spread in this plane. a 2 mg.kg-1Ropivacaine in 40 ml of saline was injected
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
morphine consumption on mg
Time Frame
day one
Secondary Outcome Measure Information:
Title
intraoperative opioid consumption
Description
total intraoperative fentanyl consumption on microg
Time Frame
Day 0
Title
Pain score after extubation
Description
simplified numerical score (SNS) after extubation [0=no pain , 10=worst pain].
Time Frame
up to 30 minutes
Title
postoperative pain score
Description
simplified numerical score (SNS) [0=no pain , 10=worst pain].
Time Frame
day one
Title
Pain score during seating position
Description
simplified numerical score (SNS) during seating position [0=no pain , 10=worst pain].
Time Frame
day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary THA with lateral approach under general anesthesia. Exclusion Criteria: Hip fracture, allergy to local anesthetics, peripheral neuropathy, creatinin clearance inferior to 30ml/min, weight inferior to 50 Kg or superior to 100 Kg, neurological disorder affecting the lower extremity, significant psychiatric conditions, patients receiving corticosteroid therapy, chronic consumption of opioids (>2 months).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olfa kaabachi
Phone
+21698317381
Email
olfa.kaabachi@gnet.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Olfa kaabachi
Phone
+21698317381
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaireddine Raddaoui, MD
Organizational Affiliation
Tunis El Manar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Kassab D'Orthopedie
City
Tunis
ZIP/Postal Code
2010
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olfa kaabachi, MD
Phone
98317381
Email
olfa.kaabachi@gnet.tn

12. IPD Sharing Statement

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Pericapsular Nerve Group Block for Total Hip Arthroplasty

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