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

NCT05003544 | Completed

• 1 other identifier: 04-2021/14
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy

Keywords

PENG block; intra-artikuler; Quadrotus lumborum block; Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) scores

  Range 0-10, 0=no pain, 10=the worse pain ever

  48 Hours

Secondary Outcomes (8)

• Opioid consumption

  3-6-8-12-24 and 48 hours

• Static and dynamic pain

  3-6-8-12-24 and 48 hours

• Presence of quadriceps motor block (defined as paralysis or paresis )

  3-6-12-24 hours after the block

• Hip adduction strength

  3-6-12-24 hours after the block

• Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression

  3-6-12-24 hours after the block

Study Arms (3)

PENG BLOCK ( Group A)

ACTIVE COMPARATOR

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

Intra-articular( Group B)

ACTIVE COMPARATOR

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

Quadratus lumborum block ( Group C)

ACTIVE COMPARATOR

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

Interventions

Group A PROCEDURE

PENG BLOCK

PENG BLOCK ( Group A)

Group B PROCEDURE

Intra-articular

Intra-articular( Group B)

Group C PROCEDURE

Quadratus lumborum block

Quadratus lumborum block ( Group C)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Tayfun Et

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30386022 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 12, 2021
• Study Start: August 25, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 20, 2022
• Last Updated: January 31, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)