PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Phase 4

Completed

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

• Registration Number: NCT05308420
• Lead Sponsor: Kresimir Oremus, MD

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.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-30
• Study Start: 2022-04-03
• Study First Posted: 2022-04-04
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PENG block	Pericapsular nerve group (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
PENG block	Spinal anesthesia	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
PENG block	Intrathecal placebo	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
Intrathecal morphine	Spinal anesthesia	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.
Intrathecal morphine	Sham PENG block	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.
Intrathecal morphine	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.

Primary Outcome Measures

Name	Time	Method
Maximum pain with active hip flexion	48 postoperative hours	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
Maximum pain at rest	48 postoperative hours	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
cumulative morphine equivalent dose over 48 post-operative hours	48 postoperative 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

Name	Time	Method
Opioid side effects	48 postoperative hours	The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded
Quadriceps muscle motor block	24 postoperative hours	Quadriceps muscle motor function will be evaluated by a straight leg raise test performed at 4,6,12,20 and 24 hours postoperatively

Trial Locations

Locations (1)

Akromion Special Hospital for Orthopedic Surgery; 🇭🇷 Krapinske Toplice, Croatia