Clinical trial NCT06282666: Lumbar ESPB in Hip Replacement Surgery
Official title: Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coxarthrosis
Pain, Postoperative
Pain, Acute
Pain, Chronic
Postoperative Pain, Chronic
Analgesia
Quality of Life
Anesthesia
Spinal
Keywords: erector spinae plane block
epidural analgesia
quality of recovery
patient-controlled analgesia
Timed Up and Go test
visual analog scale
neuropathic pain symptom inventory
Lovett scale
spinal anesthesia
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be randomly allocated to Epidural and ESPB (1:1)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opiod consumtion with PCA
timeFrame: From the admission to the postoperative care unit to the next postoperative day for 24 hours.
Secondary outcomes:
measure: Pain at rest
timeFrame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
measure: Pain upon activity
timeFrame: 24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation
measure: Lovett test
timeFrame: 24 hours before the surgery, 24 and 48 hours after the operation
measure: TUG
timeFrame: 24 hours before the surgery, 24 and 48 hours after the operation
measure: QoR-40
timeFrame: It will be measured 24 hours, 30 days, and three months following the surgery.
measure: NPSI
timeFrame: 24 hours before the surgery and 3 and 6 months following the operation
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: II Department of Anesthesia and Intensive Care
Study officials:
affiliation: Medical University of Lublin
name: Paweł Piwowarczyk, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517.