PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Sponsor
Kresimir Oremus, MD (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05308420
Collaborator
(none)
60
1
2
11.9
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular nerve group (PENG) block
  • Procedure: Spinal anesthesia
  • Drug: Intrathecal morphine
  • Procedure: Sham PENG block
  • Drug: Intrathecal placebo
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-inferiority randomized triple-blinded controlled trialNon-inferiority randomized triple-blinded controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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
Primary Purpose:
Treatment
Official Title:
Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial
Actual Study Start Date :
Apr 3, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akromion Special Hospital for Orthopedic Surgery Krapinske Toplice Croatia 49217

Sponsors and Collaborators

  • Kresimir Oremus, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kresimir Oremus, MD, Head of Division of Anesthesiology, Akromion Special Hospital for Orthopedic Surgery
ClinicalTrials.gov Identifier:
NCT05308420
Other Study ID Numbers:
  • 022021
First Posted:
Apr 4, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kresimir Oremus, MD, Head of Division of Anesthesiology, Akromion Special Hospital for Orthopedic Surgery
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022