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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TLIP | Active Comparator | Patients will receive a Thoracolumbar Plane Block (TLIPB) under ultrasound guidance while under general anesthesia. Intervention: Patients will receive a TLIPB with 20mls 0.25% Bupivicaine bilaterally. |
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| Group ESP | Experimental | Patients will receive an Erector Spinae Plane Block (ESPB) under ultrasound guidance while under general anesthesia. Intervention: Procedure: Patients will receive an ESPB with 20 ml 0.25% Bupivacaine bilaterally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLIPB | Procedure | Patients will receive TLIPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery (QoR-40) Score | 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. | Postoperative 24th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Numeric Rating Scale pain score versus time | 11-point Numerical Rating Scale pain score is measured from '0' (means no pain) to '10' (means worst pain imaginable) both at rest and during sitting. | Postoperative 24 hours |
| Numeric Rating Scale pain score |
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Inclusion Criteria:
-≥ 18 years old,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betul Basaran, MD, DESA | Karaman Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Training and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37889327 | Derived | Bilge A, Basaran B. Postoperative quality of recovery with erector spinae plane block or thoracolumbar interfascial plane block after major spinal surgery: a randomized controlled trial. Eur Spine J. 2024 Jan;33(1):68-76. doi: 10.1007/s00586-023-07998-6. Epub 2023 Oct 27. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block
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Blocks will be administered after induction of General Anesthesia so participants will be blinded to which intervention they have had.
Study investigators will not be aware of what group the participant belongs to when assessing the patient's post-operative period
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| ESPB | Procedure | Patients will receive ESPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between erector spinae muscle and transverse process of a vertebra. |
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Pain scores using a Numeric Rating Scale (NRS) ranging from 0 to 10 (0= no pain; 10= worst imaginable pain). These scores will be recorded before surgery, in PACU and 6th, 12th and 24th at the postoperative period, both at rest and during sitting. and 24th hour pain imaginable). |
| Postoperative 24 hours |
| Documentation of adverse events | Nausea and vomiting | Postoperative 24 hours |
| Postoperative opioid consumption in the first 24 hours | Subjects will be extubated, taken to the postanesthesia care unit (PACU) and will be received by a nurse blinded to randomization. A standard PACU opioid algorithm will be used which involved:
All opioid doses will be converted to morphine equivalents. | Postoperative 24 hours |
| Time for administration of first opioid analgesia | Time to administration of first opioid analgesia in the postanesthesia care unit | Postoperative 24 hours |
| Postoperative complications | Postoperative complications will be identified by visiting patients every day or alternate day during their in-hospital course, supplemented by patients' medical records review by assessors masked to group allocation, using our hospital's electronic patient record database. We will use the Claviene Dindo Classification system from which CCI is derived. We defined a postoperative complication as any deviation from the ideal postoperative course, not inherent in the procedure itself and does not constitute a failure to cure. CCI scores will be calculated using the online CCI calculator. | Postoperative thirty days |