search
Back to results

Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block (TLIPvsESP)

Primary Purpose

Spinal Surgery, Quality of Recovery, Postoperative Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TLIPB
ESPB
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Surgery focused on measuring Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Thoracolumbar Decompressive Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karaman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group TLIP

Group ESP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Numeric Rating Scale pain score
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).
Documentation of adverse events
Nausea and vomiting
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: intravenous fentanyl 25 µg for Numeric Rating Scale (NRS) pain scores of either 4 or 5 intravenous fentanyl 50 µg for NRS of 6 or greater. On discharge to the ward, subjects will be provided immediate-release oral oxycodone 5 mg every 4 hours as needed for NRS of 4-6; and 10 mg every 4 hours as needed for NRS of 7-10. All opioid doses will be converted to morphine equivalents.
Time for administration of first opioid analgesia
Time to administration of first opioid analgesia in the postanesthesia care unit
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.

Full Information

First Posted
August 19, 2021
Last Updated
May 23, 2022
Sponsor
Karaman Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05023850
Brief Title
Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block
Acronym
TLIPvsESP
Official Title
Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block for Thoracolumbar Decompressive Surgery: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Surgery, Quality of Recovery, Postoperative Analgesia, Postoperative Complications
Keywords
Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Thoracolumbar Decompressive Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group TLIP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group ESP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TLIPB
Other Intervention Name(s)
Global Quality of Recovery-40 score, Standard Pain Follow up and Monitorization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ESPB
Other Intervention Name(s)
Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Recovery (QoR-40) Score
Description
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.
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Area under the Numeric Rating Scale pain score versus time
Description
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.
Time Frame
Postoperative 24 hours
Title
Numeric Rating Scale pain score
Description
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).
Time Frame
Postoperative 24 hours
Title
Documentation of adverse events
Description
Nausea and vomiting
Time Frame
Postoperative 24 hours
Title
Postoperative opioid consumption in the first 24 hours
Description
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: intravenous fentanyl 25 µg for Numeric Rating Scale (NRS) pain scores of either 4 or 5 intravenous fentanyl 50 µg for NRS of 6 or greater. On discharge to the ward, subjects will be provided immediate-release oral oxycodone 5 mg every 4 hours as needed for NRS of 4-6; and 10 mg every 4 hours as needed for NRS of 7-10. All opioid doses will be converted to morphine equivalents.
Time Frame
Postoperative 24 hours
Title
Time for administration of first opioid analgesia
Description
Time to administration of first opioid analgesia in the postanesthesia care unit
Time Frame
Postoperative 24 hours
Title
Postoperative complications
Description
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.
Time Frame
Postoperative thirty days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betul Basaran, MD, DESA
Organizational Affiliation
Karaman Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block

We'll reach out to this number within 24 hrs