Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery

NCT ID: NCT05880017

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-01

Brief Summary

The goal of this clinical trial is to compare modified versus conventional thoracolumbar interfascial plane block for perioperative analgesia in lumber spine surgery.

The main question it aims to answer is:

• Whether modified thoracolumbar interfascial plane block is as effective as the conventional block for perioperative analgesia in lumber spine surgery.

60 patients were enrolled in the study, divided by simple random sampling into 3 groups.

Detailed Description

Spinal surgeries are usually associated with marked postoperative pain that classically takes 3 days to recede.

Adequate perioperative pain control is significant for patients to encourage early mobilization and reduce postoperative adverse events. Discectomy, laminectomy, and spinal fixation are the most frequently performed spinal surgical procedures. Extensive dissection of tissues, ligaments, and bones is often performed during spinal surgeries, resulting in a significant degree of postoperative severe pain. Adequate pain management in these patients is challenging because most of them have already received ordinary analgesics and/or opioids to ameliorate preexistent chronic back pain. Pain following spine surgery can result from mechanical irritation, nerve compression, or postoperative inflammatory processes. It can be generated from different structures such as vertebrae, discs, ligaments, muscles, dural sleeves, and capsules of the facet joint. Innervation of these pain generators is from the dorsal rami of spinal nerves. Opioids are considered the standard method of analgesia and are commonly used as effective analgesics for the management of severe pain disorders. However, their widespread use is restricted because of their side effects such as nausea, vomiting, and respiratory distress, and acquired tolerance. Preemptive multimodal analgesic regimens that rely on the synergistic action of nonopioid agents given in lower doses have been used to improve postoperative pain management and reduce opioid consumption. Protocols for reducing pain after lumbar surgery recommend the use of regional anesthesia techniques to reduce opioid analgesic use to the minimum. Interfascial plane blocks have the potential to provide extended postoperative analgesia and to reduce opioid consumption and neuraxial-related motor block to a minimum. The use of thoracolumbar interfascial plane block TLIP block was first reported in 2015 by Hand et al. wherein they did a volunteer-based study and demarcated the area of sensory analgesia. Thereafter, Ueshima et al. reported two cases of spinal surgeries where TLIP block was administered. TLIP blocks the sensory component of the dorsal rami of the thoracolumbar nerves. These nerves emerge mainly through the interface between the multifidus (MF) and longissimus (LG) muscles. Blocking these nerves provides good analgesia after spine surgeries. TLIP modification where we inject the anaesthetics between the longissimus and iliocostalis muscles after having advanced the needles at a 15 angle in a medial to lateral direction. This modified method has several advantages. 1.Advancing the needle from a medial to lateral direction eliminates the risk of possible inadvertent neuraxial injection. 2.Injecting between the iliocostalis and longissimus muscles results in a dermatomal area of analgesia similar to that obtained with an injection made between the multifidus and longissimus muscles. Both conventional and modified techniques are assumed to be effective and safe.

The primary outcome measure is postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation), time 1 ( time of delivery to PACU), every 2 hours during the first 6 hours then every 6 hours during the first 24 hours.

Conditions

Post Operative Pain Management

Study Design

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

Study Groups

Modified Group

A total of 20 patients undergoing lumber spine surgery receiving modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Group Type: ACTIVE_COMPARATOR

Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Intervention Type: PROCEDURE

Patients will be placed in a prone position; modified ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify longissimus (LG) and intercostalis muscles. After identifying the muscles and decontamination of the skin, the modified TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 15ºangle from the skin in-plane in a medial to lateral direction injecting the anesthetic locally between the longissimus and intercostalis muscles, which are easy to define using ultrasonography. After negative aspiration, injection will be in each side bilaterally in the interface between the LG and intercostalis muscles.

Bupivacain

Intervention Type: DRUG

As a local anesthetic will be injected in modified and conventional groups 20ml in each side.

Conventional Group

A total of 20 patients undergoing lumber spine surgery receiving conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Group Type: ACTIVE_COMPARATOR

Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Intervention Type: PROCEDURE

Patients will be placed in a prone position; conventional ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify the multifidus (MF) and longissimus (LG) muscles. After identifying the muscles and decontamination of the skin, the TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 30ºangle from the skin in-plane lateral to the medial direction through the belly of the LG toward the MF muscle. After negative aspiration, injection will be done in each side bilaterally in the interface between the MF and LG muscles.

Bupivacain

Intervention Type: DRUG

As a local anesthetic will be injected in modified and conventional groups 20ml in each side.

Morphine Group

A total of 20 patients undergoing lumber spine surgery receiving morphine for peritoperative analgesia (control group).

Group Type: ACTIVE_COMPARATOR

Morphine for peritoperative analgesia (control group).

Intervention Type: DRUG

Morphine based analgesia, after emergence they will receive 5mg morphine IV as a start and the rest of the first 24 hours they will receive incremental dose of intravenous morphine according to pain score.

Interventions

Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Patients will be placed in a prone position; modified ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify longissimus (LG) and intercostalis muscles. After identifying the muscles and decontamination of the skin, the modified TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 15ºangle from the skin in-plane in a medial to lateral direction injecting the anesthetic locally between the longissimus and intercostalis muscles, which are easy to define using ultrasonography. After negative aspiration, injection will be in each side bilaterally in the interface between the LG and intercostalis muscles.

Intervention Type: PROCEDURE

Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.

Patients will be placed in a prone position; conventional ultrasound guided TLIP block will be performed using a SonoSite 2-5 MHZ Curved array (C60X) transducer. The transducer will be positioned in a transverse midline position at the level of the L3 vertebra. After the identification of the spinous process and interspinous muscles, the probe will be moved laterally to identify the multifidus (MF) and longissimus (LG) muscles. After identifying the muscles and decontamination of the skin, the TLIP block will be performed under real-time ultrasound guidance using an insulated 90-mm 22G echogenic needle which will be inserted at a 30ºangle from the skin in-plane lateral to the medial direction through the belly of the LG toward the MF muscle. After negative aspiration, injection will be done in each side bilaterally in the interface between the MF and LG muscles.

Intervention Type: PROCEDURE

Morphine for peritoperative analgesia (control group).

Morphine based analgesia, after emergence they will receive 5mg morphine IV as a start and the rest of the first 24 hours they will receive incremental dose of intravenous morphine according to pain score.

Intervention Type: DRUG

Bupivacain

As a local anesthetic will be injected in modified and conventional groups 20ml in each side.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes admitted to the OR of Ain Shams University Hospitals for lumber disc surgery.
• Age 18 to 70 year old.
• ASA classification I and II.

Exclusion Criteria

• Age <18 or >70 years.
• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• Psychiatric disorder.
• ASA classification III-V.
• Patients with cerebrovascular accidents.
• Neuromuscular disorders, spine abnormalities.
• Spinal cord or head injuries.
• CNS tumours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Diaaeldein Mahmoud Haiba

Lecturer of Anesthesia, ICU and Pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams university hospitals

Cairo, Al Abbassia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Diaaeldein Ibrahim, Lecturer

Role: CONTACT

diaaeldein@med.asu.edu.eg

+201006516286

Facility Contacts

Diaaeldein M Haiba Ali Ibrahim, MD

Role: primary

diaaeldein@med.asu.edu.eg

+201006516286

Other Identifiers

FMASU R 167/2022

Identifier Type: -

Identifier Source: org_study_id