Thoracolumber Oterfacial Plane Block for Spine Surgery

Spine Surgeries Clinical Trial

— TLIP  

Official title:

Thoracolumbar Interfacial Plane Block for Analgesia After Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060681
• Other study ID #: TLIP
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2017
• Last updated: March 7, 2017
• Start date: February 15, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids and gabapentinoids .

In 2015, a promising regional analgesia technique was reported, that targets the dorsal, rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal musculature, and called this a thoracolumbar interfacial plane block (TLIP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for Spine surgery.

Exclusion Criteria:

• Spine deformities, redo surgeries, patients refusing being enrolled in the study, and patients with a bleeding tendency (INR? 1.4 and or Platelet count = 150 X103/ µl) will be excluded.

Related Conditions & MeSH terms

• Spine Surgeries

Intervention

Drug:
• Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block
After attaching basic monitors (ECG, SpO2, NIBP), the patient will take the prone position. Using the superficial probe of the ultrasound machine, the probe will be placed in transversally in midline position at selected level. The spinous process and interspinalis muscles will be identified. The probe was then moved laterally to identify the mulifidus muscle (MF) and the longissimus muscles (LG) where the local anesthetic will be injected. The needle will be advanced under real-time in-plane ultrasound guidance till it reaches the interface between the two muscles then a 1-2 ml of saline will be inserted to confirm needle site. 15 ml of bupivacaine 0.25 will be injected each side.

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	Dakahleya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morphine consumption in milligrams	morphine consumption (mg)required to keep visual anlohue scale below 4 in the 1st 24 hours after surgery	for the 1st 24 hours after surgery