Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia in Patients Undergoing Lumbar Microdiscectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1. Postoperative 48-Hour PCA Opioid Consumption
Study Overview
Brief Summary
The aim of this prospective randomized clinical study is to compare the analgesic efficacy and side effects of modified thoracolumbar interfascial plane block and quadroiliac plane block applied preoperatively in patients undergoing lumbar microdiscectomy surgery.The study will include a total of 80 patients aged 18-65 years with ASA I-III, with 40 patients in each group( Group mTLIP and Group QIPB) undergoing lumbar microdiscectomy surgery.
The primary objective of the study is to compare groups in terms of PCA opioid consumption during the 48-hour postoperative period. Secondary objectives are to compare groups in terms of QoR-15 recovery score, dynamic and static numerical rating scale scores, total rescue analgesic use, time to first request for rescue analgesia, length of hospital stay, block and opioid-related side effects and complications, and perioperative remifentanil infusion dose.
Detailed Description
Lumbar spine surgery is commonly associated with moderate to severe postoperative pain . Inadequate pain control may lead to delayed mobilisation, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar spine surgeries.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized clinical trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed before the surgery in patients undergoing elective lumbar microdiscectomy surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 65 years
- •Classified as American Society of Anesthesiologists physical status I-III
- •Scheduled for elective lumbar microdiscectomy surgery under general anesthesia
- •Provision of written informed consent
Exclusion Criteria
- •Use of anticoagulant medications or presence of bleeding diathesis
- •Known allergy or hypersensitivity to local anesthetics or opioid drugs
- •Infection at the planned block site
- •Alcohol or drug dependence
- •Cognitive impairment preventing reliable pain assessment
- •Pregnancy or lactation
- •History of previous lumbar spine surgery
- •Diabetes mellitus
- •Renal or hepatic insufficiency
Arms & Interventions
Group mTLIP
Patients in this group will undergo bilateral mTLIP block under ultrasound guidance prior to surgery.
Intervention: Modified Thoracolumbar Interfascial Plane Block (mTLIP) (Procedure)
Group QIPB
Patients in this group will undergo bilateral QIPB block under ultrasound guidance prior to surgery.
Intervention: Quadro-Iliac Plane Block (QIPB) (Procedure)
Outcomes
Primary Outcomes
1. Postoperative 48-Hour PCA Opioid Consumption
Time Frame: Time Frame: Postoperative 0-8, 8-16, 16-24 24-48 hours intervals
Description: Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
Secondary Outcomes
- QoR-15 Recovery Score(Postoperative 24th and 48th hours)
- Dynamic and static Numeric Rating Scale scores(0, 2, 4, 8, 16, 24, and 48 hours postoperatively)
- Total rescue analgesic dose(Time Frame: Postoperative 48 hours)
- Time of first request for rescue analgesia(Time Frame: Postoperative 48 hours)
- Length of Hospital Stay(the day of discharge from the hospital (assessed up to 10 days))
- Block and Opioid-Related Adverse Effects and Complications(Time Frame: Postoperative 48 hours)
- Perioperative Remifentanil infusion dose(During surgery)
Investigators
Merih Yıldız Eglen
Principal Investigator, MD
Bursa City Hospital