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Clinical Trials/NCT05023850
NCT05023850
Completed
N/A

Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block for Thoracolumbar Decompressive Surgery: a Randomized Clinical Trial

Karaman Training and Research Hospital1 site in 1 country60 target enrollmentSeptember 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Surgery
Sponsor
Karaman Training and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
Quality of Recovery (QoR-40) Score
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Major spinal surgery causes greater pain in the postoperative 24 hours. Patients with severe pain may have prolonged hospital stays and delay in mobilization. In addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing major spinal surgery.

Recently, ultrasound-guided interfascial plane blocks such as thoracolumbar interfascial plane block (TLIPB)and the erector spinae plane block (ESPB) have been described in spinal surgery. Both blocks clinically seem to be safe and easily performed. The aims of this study are to compare the quality of recovery scores, overall morbidity and postoperative analgesia after major spinal surgery in patients receiving either TLIPB or ESPB.

Detailed Description

Thoracolumbar interfascial plane block (TLIPB)and erector spinae plane block (ESPB) and have been shown to provide effective analgesia after spinal surgery. ESPB targets ventral and dorsal rami of the spinal nerve and also spreads over the paravertebral and epidural space. However, TLIPB targets only dorsal rami of the spinal nerve and spare ventral rami which may provide early ambulation. In addition, depositing local anesthetic in the fascial planes may prevent intraoperative washout. It may translate to an increase in the quality of analgesia. On the other hand, pain is an incomplete measure of postoperative recovery. No study to date has compared these two blocks in terms of the quality of recovery after major spinal surgery. This study will test the hypothesis that patients receiving TLIPB have higher QoR-40 scores in comparison with patients receiving ESPB.

Registry
clinicaltrials.gov
Start Date
September 10, 2021
End Date
May 23, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karaman Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years old,
  • Undergoing posterior lumbar spinal one to three levels fusion surgery
  • Having signed a written informed consent form,

Exclusion Criteria

  • Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,...)
  • Contraindication to nonsteroidal anti-inflammatory drugs,
  • Patient who has already had a spinal surgery,
  • Patient with chronic pain syndrome (use \> 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
  • A mental or linguistic inability to understand the study,
  • Pregnant or or breastfeeding women,
  • Patient who can not communicate in Turkish

Outcomes

Primary Outcomes

Quality of Recovery (QoR-40) Score

Time Frame: Postoperative 24th hour

QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. I rate each item on a scale of 1-5, providing a minimum score of 40 and maximum of 200.QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.Global QoR-40 scores range from 40 to 200 representing, respectively, very poor to outstanding quality of recovery. QoR-40 score will be recorded on the morning of operation and at the postoperative 24th hour.

Secondary Outcomes

  • Area under the Numeric Rating Scale pain score versus time(Postoperative 24 hours)
  • Postoperative complications(Postoperative thirty days)
  • Documentation of adverse events(Postoperative 24 hours)
  • Time for administration of first opioid analgesia(Postoperative 24 hours)
  • Numeric Rating Scale pain score(Postoperative 24 hours)
  • Postoperative opioid consumption in the first 24 hours(Postoperative 24 hours)

Study Sites (1)

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