Clinical trial NCT05023850: Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block
Official title: Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block for Thoracolumbar Decompressive Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Surgery
Quality of Recovery
Postoperative Analgesia
Postoperative Complications
Keywords: Thoracolumbar Interfascial Plane Block
Erector Spinae Plane Block
Thoracolumbar Decompressive Surgery
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

-≥ 18 years old,

* Undergoing posterior lumbar spinal one to three levels fusion surgery
* Having signed a written informed consent form,
* ASAI-III

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

Primary outcomes:
measure: Quality of Recovery (QoR-40) Score
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Area under the Numeric Rating Scale pain score versus time
timeFrame: Postoperative 24 hours
measure: Numeric Rating Scale pain score
timeFrame: Postoperative 24 hours
measure: Documentation of adverse events
timeFrame: Postoperative 24 hours
measure: Postoperative opioid consumption in the first 24 hours
timeFrame: Postoperative 24 hours
measure: Time for administration of first opioid analgesia
timeFrame: Postoperative 24 hours
measure: Postoperative complications
timeFrame: Postoperative thirty days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betul Basaran, MD, DESA
role: STUDY_DIRECTOR
References: