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mTLIP vs QIPB for Postoperative Analgesia After Lumbar Instrumentation Surgery

ConditionPain, Postoperative
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital

About this trial

Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

Classified as American Society of Anesthesiologists physical status I-III

Scheduled for elective lumbar instrumentation 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/Surgery

    An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).

  • Quadro-Iliac Plane Block (QIPB):

    Procedure/Surgery

    An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Modified Thoracolumbar Interfascial Plane Block (mTLIP) GroupExperimental treatment 1 intervention
Group B: Quadro-Iliac Plane Block (QIPB) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative 48-Hour PCA Opioid Consumption

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
Postoperative 0-8, 8-16, 16-24, 24-48 intervals

Secondary 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 hours
2

Dynamic and static Numeric Rating Scale scores

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 postoperatively
3

Total rescue analgesic dose

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
Postoperative 48 hours
4

Time of first request for rescue analgesia

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
Postoperative 48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa City Hospital

Lead sponsor

Source ClinicalTrials.gov

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