Thoracolumber Oterfacial Plane Block for Spine Surgery

NCT03060681 | Unknown DMC

• 1 other identifier: TLIP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

T group

EXPERIMENTAL

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.

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

C group

NO INTERVENTION

Interventions

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

T group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for Spine surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 23, 2017
• Study Start: February 15, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

EG (1)