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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931343
Acronym
TALIPES
Enrollment
60
Registered
2019-04-30
Start date
2020-12-31
Completion date
2021-04-30
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Postoperative Nausea and Vomiting, Postoperative Pain

Keywords

Thoracolumbar interfascial block, Erector spinae plane block

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.

Interventions

PROCEDUREBilateral 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

PROCEDUREBilateral 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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumption48 hourThe total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.

Secondary

MeasureTime frameDescription
Pain intensity score at rest48 hourChanges 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 )
Pain intensity score at movement48 hourChanges 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 )
Time to first rescue analgesia48 hourIf VAS is greater than 3, 25 mg of meperidine will be administered.
Postoperative nausea and vomiting48 hourChanges 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)
Patient satisfaction score48 hourWill be scored between 1-5 (1- very bad 5-very good).

Contacts

Primary ContactSerdar Yeşiltaş
syesiltas@bezmialem.edu.tr+905423632630
Backup ContactSinan Yılmaz
syilmaz@bezmialem.edu.tr+905324563023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026