Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery

NCT03931343 | Unknown DMC

• 1 other identifier: S002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Opioid Use

Keywords

Thoracolumbar interfascial block, Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.

  48 hour

Secondary Outcomes (5)

• Pain intensity score at rest

  48 hour

• Pain intensity score at movement

  48 hour

• Time to first rescue analgesia

  48 hour

• Postoperative nausea and vomiting

  48 hour

• Patient satisfaction score

  48 hour

Study Arms (2)

Thoracolumbar interfascial plane block

EXPERIMENTAL

Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance

Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance

Erectro spinae plane block

ACTIVE COMPARATOR

Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance

Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance

Interventions

Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance PROCEDURE

Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance

Also known as: Thoracolumbar interfascial plane block

Thoracolumbar interfascial plane block

Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance PROCEDURE

Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance

Also known as: Erector spinae plane block

Erectro spinae plane block

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• ASA 1-2-3
• Patients scheduled for elective surgery

You may not qualify if:

• Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
• Allergy to drugs
• Major cardiac disease
• Renal failure
• Psychiatric disease
• Patients who refuse to participate in the study
• Chronic back and lower back pain

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Serdar Yeşiltaş

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Yeşiltaş

CONTACT

+905423632630; syesiltas@bezmialem.edu.tr

Sinan Yılmaz

CONTACT

+905324563023; syilmaz@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: İnstructor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share