Clinical trial NCT05308420: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Hip Arthroplasty
Postoperative Pain
Keywords: Total hip arthroplasty
Postoperative pain
Anesthesia, Regional
Lead sponsor: Akromion Special Hospital for Orthopedic Surgery
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized triple-blinded controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum pain at rest
timeFrame: 48 postoperative hours
measure: Maximum pain with active hip flexion
timeFrame: 48 postoperative hours
measure: cumulative morphine equivalent dose over 48 post-operative hours
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: Quadriceps muscle motor block
timeFrame: 24 postoperative hours
measure: Opioid side effects
timeFrame: 48 postoperative hours
Other outcomes:
Locations:
city: Krapinske Toplice
country: Croatia
facility: Akromion Special Hospital for Orthopedic Surgery
Study officials:
References:
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.
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.
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.