Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Lublin
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Opiod consumtion with PCA
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.
Physiotherapists assessing outcomes will not be aware of patient allocation.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Opiod consumtion with PCA
Time Frame: 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 Outcomes
- QoR-40(It will be measured 24 hours, 30 days, and three months following the surgery.)
- 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)
- Lovett test(24 hours before the surgery, 24 and 48 hours after the operation)
- 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)
- TUG(24 hours before the surgery, 24 and 48 hours after the operation)
- NPSI(24 hours before the surgery and 3 and 6 months following the operation)
Investigators
Michał Borys
MD, PhD
Medical University of Lublin