Back to resultsPENG Block vs Intrathecal Morphine in Total Hip Arthroplasty
Primary Purpose
Total Hip Arthroplasty, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Pericapsular nerve group (PENG) block
Spinal anesthesia
Intrathecal morphine
Sham PENG block
Intrathecal placebo
Sponsored by
About this trial
This is an interventional treatment trial for Total Hip Arthroplasty focused on measuring Total hip arthroplasty, Postoperative pain, Anesthesia, Regional
Eligibility Criteria
Inclusion Criteria:
- adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent
Exclusion Criteria:
- patient unwilling / unable to provide informed consent
- contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
- high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
- preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
- pregnancy
- substance abuse
Post Randomization Exclusion Criteria:
- change of surgical plan
- violation of study protocol
Sites / Locations
- Akromion Special Hospital for Orthopedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PENG block
Intrathecal morphine
Arm Description
Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.
Outcomes
Primary Outcome Measures
Maximum pain at rest
maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Maximum pain with active hip flexion
maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
cumulative morphine equivalent dose over 48 post-operative hours
cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Secondary Outcome Measures
Quadriceps muscle motor block
Quadriceps muscle motor function will be evaluated by a straight leg raise test performed at 4,6,12,20 and 24 hours postoperatively
Opioid side effects
The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05308420
Brief Title
PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty
Official Title
Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kresimir Oremus, MD
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
To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.
Detailed Description
The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Postoperative Pain
Keywords
Total hip arthroplasty, Postoperative pain, Anesthesia, Regional
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Non-inferiority randomized triple-blinded controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered. Outcome assessor/statistician will be blinded as to which group received which intervention
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENG block
Arm Type
Active Comparator
Arm Description
Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone
Arm Title
Intrathecal morphine
Arm Type
Active Comparator
Arm Description
Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed.
Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group (PENG) block
Intervention Description
A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine
Intervention Description
100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)
Intervention Type
Procedure
Intervention Name(s)
Sham PENG block
Intervention Description
A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule
Intervention Type
Drug
Intervention Name(s)
Intrathecal placebo
Intervention Description
0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)
Primary Outcome Measure Information:
Title
Maximum pain at rest
Description
maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Time Frame
48 postoperative hours
Title
Maximum pain with active hip flexion
Description
maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Time Frame
48 postoperative hours
Title
cumulative morphine equivalent dose over 48 post-operative hours
Description
cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes
Time Frame
48 postoperative hours
Secondary Outcome Measure Information:
Title
Quadriceps muscle motor block
Description
Quadriceps muscle motor function will be evaluated by a straight leg raise test performed at 4,6,12,20 and 24 hours postoperatively
Time Frame
24 postoperative hours
Title
Opioid side effects
Description
The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded
Time Frame
48 postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent
Exclusion Criteria:
patient unwilling / unable to provide informed consent
contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
pregnancy
substance abuse
Post Randomization Exclusion Criteria:
change of surgical plan
violation of study protocol
Facility Information:
Facility Name
Akromion Special Hospital for Orthopedic Surgery
City
Krapinske Toplice
ZIP/Postal Code
49217
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30063657
Citation
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.
Results Reference
background
PubMed Identifier
30105593
Citation
Hess SR, Lahaye LA, Waligora AC, Sima AP, Jiranek WA, Golladay GJ. Safety and side-effect profile of intrathecal morphine in a diverse patient population undergoing total knee and hip arthroplasty. Eur J Orthop Surg Traumatol. 2019 Jan;29(1):125-129. doi: 10.1007/s00590-018-2293-9. Epub 2018 Aug 13.
Results Reference
background
PubMed Identifier
34015859
Citation
Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
Results Reference
background
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PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty
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