mTLIP vs QIPB for Postoperative Analgesia in Lumbar Microdiscectomy Surgery
ConditionPostoperative Pain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Thoracolumbar Interfascial Plane Block (mTLIP)
Procedure/SurgeryThis is a fascial plane block in which a local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles. Participants in this group will undergo bilateral modified thoracolumbar interfascial plane blocks (mTLIP) under ultrasound guidance prior to surgery. Under sterile conditions, with the patient in the prone position, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the lumbar levels to be operated on. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. Correct needle placement will be confirmed with saline solution. A total of 40 mL of 0.25% bupivacaine and 5 µg/mL (1:200,000) adrenaline-containing local anesthetic solution (20 mL for each side) will be used for the block procedures.
Quadro-Iliac Plane Block (QIPB)
Procedure/SurgeryThis is a fascial plane block is a procedure in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing it to spread between the erector spinae and quadratus lumborum muscles. Participants in the QIPB Group will undergo bilateral quadrioliac plane blocks (QIPB) under ultrasound guidance prior to surgery. Under sterile conditions, with the patient in the prone position, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest to identify the erector spinae and quadratus lumborum muscles. After confirming the needle placement with saline, a local anesthetic solution containing 0.25% bupivacaine and 5 µg/mL (1:200,000) adrenaline will be administered, total 40 mL (20 mL for each side). The spread of the local anesthetic solution between the erector spinae and quadratus lumborum muscles will be visualized
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Group mTLIPExperimental treatment 1 intervention
Group B: Group QIPBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1. Postoperative 48-Hour PCA Opioid Consumption
Description: Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
Time frame
Time Frame: Postoperative 0-8, 8-16, 16-24 24-48 hours intervalsSecondary outcomes
1
QoR-15 Recovery Score
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
Time frame
Postoperative 24th and 48th hours2
Dynamic and static Numeric Rating Scale scores
Description: Numeric Rating Scale (NRS) (0-10; 0= no pain, 10 = the most severe pain felt) pain scores at rest or movement at predefined postoperative hours
Time frame
0, 2, 4, 8, 16, 24, and 48 hours postoperatively3
Total rescue analgesic dose
Description: Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia. Total amount of meperidin during the first 24 and 48 hours after surgery, recorded in milligrams (mg).
Time frame
Time Frame: Postoperative 48 hours4
Time of first request for rescue analgesia
Description: Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
Time frame
Time Frame: Postoperative 48 hoursSponsors and contacts
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Source ClinicalTrials.gov