PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Pericapsular nerve group (PENG) block; Procedure: Spinal anesthesia; Drug: Intrathecal placebo; Drug: Intrathecal morphine; Procedure: Sham PENG block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Krapinske Toplice, Croatia, 49217
    • Akromion Special Hospital for Orthopedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PENG block; 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	Procedure: Pericapsular nerve group (PENG) block; 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; Procedure: Spinal anesthesia; 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; Drug: Intrathecal placebo; 0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)
Active Comparator: Intrathecal morphine; 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.	Procedure: Spinal anesthesia; 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; Drug: Intrathecal morphine; 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); Procedure: Sham PENG block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 postoperative hours
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	48 postoperative hours
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	48 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 postoperative hours
Opioid side effects	The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded	48 postoperative hours

Collaborators and Investigators

• Sponsor: Kresimir Oremus, MD

Publications and helpful links

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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Postoperative pain; Anesthesia, Regional
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 022021

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