Thoracolumber Oterfacial Plane Block for Spine Surgery

NCT ID: NCT03060681

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2018-02-20

Brief 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).

Conditions

Spine Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

T group

Ultrasound guided Bilateral TLIP Block will be performed 15 minute before the start of surgery Using 15 ml of bupivacaine 0.25 for each side.

Group Type: EXPERIMENTAL

Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block

Intervention Type: DRUG

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.

C group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

AlRefaey Kandeel

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Amr Yassen

Role: primary

ameyassen@hotmail.com

Other Identifiers

TLIP

Identifier Type: -

Identifier Source: org_study_id