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Erector Spinae Plane Block vs Quadro-Iliac Plane Block After Lumbar Instrumentation Surgery

ConditionPain, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital

About this trial

Lumbar instrumentation surgery is associated with significant postoperative pain. This study compares the postoperative analgesic effectiveness of ultrasound-guided Erector Spinae Plane Block and 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

  • Erector Spinae Plane Block

    Procedure/Surgery

    An ultrasound-guided Erector Spinae Plane Block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. The ultrasound probe will be placed in the parasagittal plane at the level corresponding to the surgical site to visualize the transverse process and erector spinae muscle. Following confirmation of correct needle placement with 2 mL of normal saline, 20 mL of 0.25% bupivacaine will be injected into the fascial plane deep to the erector spinae muscle. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.

  • Quadro-Iliac Plane Block

    Procedure/Surgery

    An ultrasound-guided Quadro-Iliac Plane Block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. A convex ultrasound probe will be placed at the level where the quadratus lumborum muscle attaches to the iliac crest to visualize the erector spinae muscle and the underlying quadratus lumborum muscle. The block location will be confirmed with the injection of 2 mL of isotonic solution, followed by the injection of 20 mL of 0.25% bupivacaine. The spread of the local anesthetic between the erector spinae muscle and quadratus lumborum muscle will be observed under ultrasound guidance. The block will be performed bilaterally, with a total volume of 40 mL, as part of a standardized multimodal postoperative analgesia protocol.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Erector Spinae Plane Block (ESPB)Active comparator 1 intervention
Group B: Quadro-Iliac Plane Block (QIPB)Active comparator 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 24th and 48th 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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