Lumbar ESPB in Hip Replacement Surgery

Not Applicable

Recruiting

• Conditions: Spinal; Coxarthrosis; Pain, Acute; Pain, Chronic; Pain, Postoperative; Analgesia; Postoperative Pain, Chronic; Quality of Life; Anesthesia

• Registration Number: NCT06282666
• Lead Sponsor: Medical University of Lublin

Brief Summary

In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.

Detailed Description

This is a prospective trial in patients undergoing elective hip replacement surgery.

Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.

Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.

Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.

After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.

Study Timeline

• Study First Submitted: 2024-02-12
• Study Start: 2024-02-19
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-02-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• primary hip replacement surgery due to coxarthrosis
• anesthetized with spinal technique
• able to use PCA pump
• having access to phone

Exclusion Criteria

• patients taking painkillers not related to coxarthrosis;
• having active cancer,
• dementia or challenging contact with the patient;
• suffering from depression or other psychiatric disorders that required antidepressant treatment;
• consuming alcohol or recreational drug addiction;
• contraindications to the regional block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opiod consumtion with PCA	From the admission to the postoperative care unit to the next postoperative day for 24 hours.	Oxycodone consumtion used with a patient-controlled analgesia pump

Secondary Outcome Measures

Name	Time	Method
QoR-40	It will be measured 24 hours, 30 days, and three months following the surgery.	quality of recovery 40
Pain upon activity	24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation	Pain measured upon activity on the VAS (0-10)
Lovett test	24 hours before the surgery, 24 and 48 hours after the operation	The quadriceps femori's muscle strength on the Lovett scale (0-5)
Pain at rest	24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation	Pain measured at rest on the VAS (0-10)
TUG	24 hours before the surgery, 24 and 48 hours after the operation	Timed Up and Go test in seconds
NPSI	24 hours before the surgery and 3 and 6 months following the operation	The Neuropathic Pain Symptom Inventory will be measured personally and after the discharge with a phone interview.

Trial Locations

Locations (1)

II Department of Anesthesia and Intensive Care; 🇵🇱 Lublin, Poland