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

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003544
• Other study ID #: 04-2021/14
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: September 2022
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 20, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Procedure:
• Group A
PENG BLOCK
• Group B
Intra-articular
• Group C
Quadratus lumborum block

Locations

Country	Name	City	State
Turkey	Tayfun Et	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) scores	Range 0-10, 0=no pain, 10=the worse pain ever	48 Hours
Secondary	Opioid consumption	Analgesic consumption	3-6-8-12-24 and 48 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Secondary	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
Secondary	Mobilization time	Mobilization time	24 hour