Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty

Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty: : Randomized Controlled Double Blinded Trial Trial

90 patients ASA I-III, undergoing Total hip arthroplasty (THA) under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=30), where an PENG block, group B (N:30) where an inra-articuler, and group C (n=30) where Quadratus lumborum block will be performed preoperatively. All patients will receive a standardized postoperative analgesia regimen. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.

Study Overview

• Status: Completed
• Conditions: Hip Arthropathy
• Intervention / Treatment: Procedure: Group A; Procedure: Group B; Procedure: Group C

Detailed Description

Total hip arthroplasty (THA) is the second most common joint replacement surgery, partly due to the aging population. The primary aim of this study is to compare the analgesic efficacy of Pericapsular nerve group (PENG) block with intra-articular and Quadrotus lumborum block (QLB). Regional anesthesia (RA), such as the recently described pericapsular nerve group (PENG) block, may provide additional analgesic benefit in this situation. Pericapsular nerve group (PENG) block is a new regional anesthesia technique to provide analgesia after hip fractures and hip arthroplasty. The aim of this single-center, double-blind, randomized controlled trial is to confirm the efficacy of PENG block for postoperative recovery after primary THA.

Routine multimodal analgesia will be used for postoperative analgesia

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Tayfun Et

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

• Previous operation on the same hip
• Hepatic or renal insufficiency
• Younger than 18 years old and older than 85
• Patients undergoing general anesthesia
• Allergy or intolerance to one of the study medications
• BMI >40
• ASA IV
• Chronic gabapentin/pregabalin use ( regular use for longer than 3 months)
• Chronic opioid use ( taking opioids for longer than 3 months, or daily oral morphine equivalent of >5 mg/day one month

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PENG BLOCK ( Group A); A regional block will be applied while the patient is in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) will initially be placed in a transverse plane on the AIIS and then rotate the probe approximately 45 degrees counterclockwise to align with the pubic ramus. In this view, IPE, iliopsoas muscle and tendon, femoral artery and pectineus muscle will be observed. A 22 gauge, 80 mm needle will be inserted from lateral to medial in an in-plane approach to place the psoas tendon anteriorly and posteriorly in the musculofacial plane between the pubic ramus. Following negative aspiration, a local anesthetic solution (20ml bupivacaine 0.5%) will be injected.	Procedure: Group A; PENG BLOCK
Active Comparator: Intra-articular( Group B); It will be applied to the intra-articular region by the surgeon at the end of the operation. A volume of 60 ml (30 ml of 0.5% bupivacaine and 30 ml of 0.9% NaCl)	Procedure: Group B; Intra-articular
Active Comparator: Quadratus lumborum block ( Group C); The patient will be in the lateral position. A low-frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in-plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.5 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.	Procedure: Group C; Quadratus lumborum block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) scores	Range 0-10, 0=no pain, 10=the worse pain ever	48 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Analgesic consumption	3-6-8-12-24 and 48 hours
Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) 0 = no pain and 10 = worst imaginable painranged from 0 to 10	3-6-8-12-24 and 48 hours
Presence of quadriceps motor block (defined as paralysis or paresis )	Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	3-6-12-24 hours after the block
Hip adduction strength	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively	3-6-12-24 hours after the block
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression	Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio	3-6-12-24 hours after the block
Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Quality of Recovery (QoR-40) score	QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.	measurements are obtained at 24 hours, 48 hours, and one week
Mobilization time	Mobilization time	24 hour

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital

Publications and helpful links

General Publications

• Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: PENG block; intra-artikuler; Quadrotus lumborum block; Hip Arthropathy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 04-2021/14

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