PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations.
M Anger, T Valovska, H Beloeil...
https://pubmed.ncbi.nlm.nih.gov/34015859Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06317870
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty: a Double Blind, Non-inferiority Study
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2024-08-22
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pain relief effect of a pericapsular nerve block (PENG) compared to intrathecal morphine in patients undergoing total hip replacement surgery. This double-blind, non-inferiority study aims to determine if the PENG block provides similar postoperative pain control as intrathecal morphine by comparing morphine consumption, pain scores, side effects, and functional outcomes. Eighty patients will be randomly divided into two groups. One group will receive spinal anesthesia with local anesthetic and a PENG block, while the other will receive spinal anesthesia with local anesthetic plus intrathecal morphine and a sham PENG block to maintain blinding. During surgery, additional medications like dexamethasone, acetaminophen, ketorolac, and magnesium will support postoperative pain control. After surgery, pain will be managed with morphine as needed, along with paracetamol and ibuprofen. Participants will be closely monitored with post-operative visits at 2 hours, 1 day, and 2 days after surgery to collect data on pain, morphine use, side effects, and functional tests like walking and muscle strength. Pain management and any side effects such as nausea, itching, or urinary retention will be recorded. The main outcome is the total morphine used within the first 24 hours after surgery, with additional measures taken up to 2 days postoperatively.
CONDITIONS
Brief Title
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients
- ASA (American Society of Anaesthesiologists) physical status I-III
- 18 years of age or older
- Scheduled for elective primary hip arthroplasty
- Able to give written informed consent independently
You will not qualify if you...
- Refusal or inability to give consent
- Allergy to ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron, or dexamethasone
- Bleeding disorders
- Neurological deficits on the side to be operated
- Current use of opioids before surgery
- Kidney failure with filtration rate below 30 ml/min
- Liver failure
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 2 hours post-surgery
Participants receive spinal anesthesia followed by either a pericapsular nerve group block or intrathecal morphine during their hip arthroplasty surgery. Postoperative analgesia is managed in the recovery room with additional medications and morphine as needed.
1 visit (in-person, surgery and recovery room care)
Post-operative Follow-up
Duration - 2 days post-surgery
Participants are monitored for pain, morphine consumption, side effects, and functional recovery. Pain scores, morphine use, and adverse effects are recorded at 2 hours, day 1, and day 2 postoperatively. Functional tests such as quadriceps strength and walking tests are performed on days 1 and 2.
3 visits (at 2 hours, day 1, and day 2 post-surgery)
Trial Site Locations
Total: 1 location
1
University Hospital of Lausanne
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
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Research Team
E
Eric Albrecht, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy and safety of intrathecal morphine for analgesia after lower joint arthroplasty: a systematic review and meta-analysis with meta-regression and trial sequential analysis.
E Gonvers, K El-Boghdadly, S Grape...
https://pubmed.ncbi.nlm.nih.gov/34448492Effect of different low doses of intrathecal morphine (0.1 and 0.2 mg) on pain and vital functions in patients undergoing total hip arthroplasty: a randomised controlled study.
Eva Vitola, Natalija Buraka, Renars Erts...
https://pubmed.ncbi.nlm.nih.gov/36471258Postoperative pain relief after total hip arthroplasty: a randomized, double-blind comparison between intrathecal morphine and local infiltration analgesia.
J Kuchálik, B Granath, A Ljunggren...
https://pubmed.ncbi.nlm.nih.gov/23872462Intrathecal morphine provides better postoperative analgesia than psoas compartment block after primary hip arthroplasty.
Vincent Souron, Laurent Delaunay, Patrick Schifrine
https://pubmed.ncbi.nlm.nih.gov/12826549A randomised, controlled, double blind, non-inferiority trial of ultrasound-guided fascia iliaca block vs. spinal morphine for analgesia after primary hip arthroplasty.
R Kearns, A Macfarlane, A Grant...
https://pubmed.ncbi.nlm.nih.gov/27714758PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations.
E Roofthooft, G P Joshi, N Rawal...
https://pubmed.ncbi.nlm.nih.gov/33370462Pericapsular Nerve Group (PENG) Block for Hip Fracture.
Laura Girón-Arango, Philip W H Peng, Ki Jinn Chin...
https://pubmed.ncbi.nlm.nih.gov/30063657Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial.
G Pascarella, F Costa, R Del Buono...
https://pubmed.ncbi.nlm.nih.gov/34196965The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial.
D-Yin Lin, Brigid Brown, Craig Morrison...
https://pubmed.ncbi.nlm.nih.gov/35933328