- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04306133
PENG Block Combined to Wound Infiltration for Hip Replacement
April 5, 2021 updated by: Giuseppe Pascarella, Campus Bio-Medico University
Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.
Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy
- Università Campus Biomedico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective hip replacement surgery
- ASA physical status score < 4
Exclusion Criteria:
- Contraindications to regional anesthesia
- ASA physical status score ≥ 4
- Patient's refusal or inability to sing the informed consent
- Pre-operatively therapy with opioids
- Allergies to any drug provided by the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PENG BLOCK AND WOUND INFILTRATION
Participants receiving PENG block combined to wound infiltration
|
After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe.
A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.
|
Active Comparator: WOUND INFILTRATION
Participants receiving wound infiltration alone
|
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Pain Score
Time Frame: 24 hours
|
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain during 48 h after surgery
|
24 hours
|
Total opioids consumption
Time Frame: 48 hours
|
Total of Sublingual Sufentanil tablets released
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48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first opioid
Time Frame: 48 hours
|
Time (hours) from the end of surgery to the first opioid administration
|
48 hours
|
Range of hip motion
Time Frame: 24 hours
|
Degrees of hip flexion
|
24 hours
|
Time to ambulation
Time Frame: 48 hours
|
Time until the patient is able to stand up and walk with or without assistive devices
|
48 hours
|
Quadriceps weakness
Time Frame: 48 hours
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Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion
|
48 hours
|
Incidence of block complications
Time Frame: 48 hours
|
Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.
|
48 hours
|
Opioids side effects
Time Frame: 48 hours
|
The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giuseppe Pascarella, MD, University Hospital Campus Biomedico of Rome
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
- Pascarella G, Costa F, Del Buono R, Pulitanò R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agrò 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2020
Primary Completion (Actual)
December 24, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
March 8, 2020
First Submitted That Met QC Criteria
March 10, 2020
First Posted (Actual)
March 12, 2020
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29/20 PAR ComEt CBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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