Pain Management
Conditions
Brief summary
This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy. Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.
Detailed description
This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy. Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia. All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.
Interventions
PROCEDUREUltrasound-Guided Quadro-Iliac Plane Block
Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
PROCEDURELocal Infiltration Analgesia (LIA)
Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and the postoperative outcomes assessor will be blinded to group allocation. The anesthesiologist performing the block procedure will not take part in postoperative data collection or outcome assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 75 years * American Society of Anesthesiologists physical status I to III * Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation * Planned surgery under general anesthesia * Able to provide written informed consent
Exclusion criteria
* Allergy or hypersensitivity to local anesthetics * Coagulopathy or active anticoagulant use * Infection, scar tissue, or skin lesion at the injection site * Pregnancy or breastfeeding * Chronic pain syndrome or regular opioid use * American Society of Anesthesiologists physical status IV or higher * Planned surgery for two or more levels of disc herniation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Fentanyl Consumption During the First 24 Hours After Surgery | Postoperative 0-24 hours | Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores at Rest and During Movement | Postoperative 0, 1, 6, 12, and 24 hours | Pain intensity will be assessed using the Numerical Rating Scale at rest and during movement. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Rescue Analgesic Requirement | Postoperative 0-24 hours | The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period. |
| Opioid-Related Adverse Effects | Postoperative 0-24 hours | Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded. |
| Quality of Recovery Score | Postoperative 24 hours | Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire. |
| Dermatomal Sensory Spread | Postoperative 2 hours | Dermatomal sensory spread of the block will be evaluated using a cold test. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEngin ihsan Turan, principal investigator
Outcome results
None listed