Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block

NCT05023850 | Completed

• 1 other identifier: 05-2021/13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Surgery; Quality of Recovery; Postoperative Analgesia; Postoperative Complications

Keywords

Thoracolumbar Interfascial Plane Block; Erector Spinae Plane Block; Thoracolumbar Decompressive Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Area under the Numeric Rating Scale pain score versus time

  Postoperative 24 hours

• Numeric Rating Scale pain score

  Postoperative 24 hours

• Documentation of adverse events

  Postoperative 24 hours

• Postoperative opioid consumption in the first 24 hours

  Postoperative 24 hours

• Time for administration of first opioid analgesia

  Postoperative 24 hours

Study Arms (2)

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.

Procedure: TLIPB

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.

Procedure: ESPB

Interventions

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.

Also known as: Global Quality of Recovery-40 score, Standard Pain Follow up and Monitorization

Group TLIP

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.

Also known as: Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization

Group ESP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Betul Basaran, MD, DESA

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 27, 2021
• Study Start: September 10, 2021
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: May 24, 2022

Record last verified: 2021-09

Locations

TU (1)