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

Postoperative Pain Clinical Trial

— TALIPES  

Official title:

Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03931343
• Other study ID #: S002
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: April 2021

Study information

• Verified date: October 2020
• Source: Bezmialem Vakif University
• Contact: Serdar Yesiltas
• Phone: +905423632630
• Email: syesiltas[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 20-75 years

2. ASA 1-2-3

3. Patients scheduled for elective surgery

Exclusion Criteria:

1. Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)

2. Allergy to drugs

3. Major cardiac disease

4. Renal failure

5. Psychiatric disease

6. Patients who refuse to participate in the study

7. Chronic back and lower back pain

Related Conditions & MeSH terms

• Opioid Use
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

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
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
• 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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.	48 hour
Secondary	Pain intensity score at rest	Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )	48 hour
Secondary	Pain intensity score at movement	Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )	48 hour
Secondary	Time to first rescue analgesia	If VAS is greater than 3, 25 mg of meperidine will be administered.	48 hour
Secondary	Postoperative nausea and vomiting	Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)	48 hour
Secondary	Patient satisfaction score	Will be scored between 1-5 (1- very bad 5-very good).	48 hour