Nerve Block, Postoperative Pain, Randomised Clinical Trial
Conditions
Keywords
POSTOPERATİVE PAİN, ERECTOR SPİNA PLANE BLOCK, LUMBAR SPİNAL SURGERY
Brief summary
The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are: Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur. Participants: Patients in this study will be asked to: Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy Undergo postoperative follow-up including: measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects
Detailed description
This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia. Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine surgery.
Interventions
PROCEDUREESP block group
BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.
Sponsors
Kutahya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18 and over, 80 and under * American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ * Patients who can cooperate and give consent * No chronic analgesic or opioid use * No mental or psychiatric disorders * No alcohol or illicit drug use * Patients scheduled for elective spinal surgery
Exclusion criteria
* -Patients who withdrew from participation at any time during the study * Foreign nationals who could not be contacted * Patients under 18 and over 80 * Patients with an ASA score of Ⅳ or higher * Patients scheduled for emergency surgery * Pregnant women and breastfeeding mothers * Bleeding diathesis * Drug allergy * Anticoagulant use * Local/systemic infection * Serious arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS values of patients in the first 24 hours postoperatively | The first 24 hours postoperatively | Zero indicates no pain, and 10 indicates the worst possible pain |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORmerve kaynak
Kütahya City Hospital
STUDY_CHAIRAli Kaynak
Kütahya City Hospital
STUDY_CHAIRbilal a bezen
Afyonkarahisar Health Sciences University Hospital
STUDY_DIRECTORremziye sıvacı
Afyonkarahisar Health Sciences University Hospital
STUDY_CHAIRelif d bakı
Afyonkarahisar Health Sciences University Hospital
STUDY_CHAIRserhat yıldızhan
Afyonkarahisar Health Sciences University Hospital
Outcome results
None listed