PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Kresimir Oremus, MD60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Total Hip Arthroplasty Postoperative Pain

Interventions

Pericapsular nerve group (PENG) blockPROCEDURE

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

Spinal anesthesiaPROCEDURE

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

Intrathecal morphine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Akromion Special Hospital for Orthopedic Surgery

Krapinske Toplice, Croatia

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 48 postoperative hours

Secondary Outcomes

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

Time frame: 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

Time frame: 48 postoperative hours

Data from ClinicalTrials.gov

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