Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block

NCT ID: NCT05023850

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-05-23

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group TLIP

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.

Group Type: ACTIVE_COMPARATOR

TLIPB

Intervention Type: 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.

Group ESP

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.

Group Type: EXPERIMENTAL

ESPB

Intervention Type: 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.

Interventions

TLIPB

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

ESPB

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.

Intervention Type: PROCEDURE

Other Intervention Names

Global Quality of Recovery-40 score; Standard Pain Follow up and Monitorization; Global Quality of Recovery-40 score; Standard Pain Followup and Monitorization

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betul Basaran, MD, DESA

Role: STUDY_DIRECTOR

Karaman Training and Research Hospital

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

05-2021/13

Identifier Type: -

Identifier Source: org_study_id