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Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery

Primary Purpose

Post Operative Pain Management

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Morphine for peritoperative analgesia (control group).
Bupivacain
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain Management focused on measuring Thoracolumber, Interfascial plane, Lumber discectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Modified Group

Conventional Group

Morphine Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."

Secondary Outcome Measures

Pain intensity expressed as A numerical rating scale (NRS) score at time 1 (time of delivery to Post Anesthesia Care Unit PACU).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Pain intensity expressed as A numerical rating scale (NRS) score at time 6 (6 hours postoperative).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Pain intensity expressed as A numerical rating scale (NRS) score at time 24 (24 hours postoperative).
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Early ambulation.
Time of starting ambulation postoperative
Time of first rescue analgesic.
As-needed dose of opioid (morphine) to provide relief of first breakthrough pain.
Total dose of Postoperative morphine consumption during first 24 hours.
Dose of morphine in milligram

Full Information

First Posted
May 5, 2023
Last Updated
May 19, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05880017
Brief Title
Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery
Official Title
Modified Versus Conventional Thoracolumbar Interfascial Plane Block for Perioperative Analgesia in Lumber Spine Surgery. A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Management
Keywords
Thoracolumber, Interfascial plane, Lumber discectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective , randomized controlled, comparative study.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Group
Arm Type
Active Comparator
Arm Description
A total of 20 patients undergoing lumber spine surgery receiving modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
A total of 20 patients undergoing lumber spine surgery receiving conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Arm Title
Morphine Group
Arm Type
Active Comparator
Arm Description
A total of 20 patients undergoing lumber spine surgery receiving morphine for peritoperative analgesia (control group).
Intervention Type
Procedure
Intervention Name(s)
Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Intervention Description
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
Intervention Name(s)
Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.
Intervention Description
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
Drug
Intervention Name(s)
Morphine for peritoperative analgesia (control group).
Intervention Description
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
Intervention Name(s)
Bupivacain
Intervention Description
As a local anesthetic will be injected in modified and conventional groups 20ml in each side.
Primary Outcome Measure Information:
Title
postoperative pain intensity expressed as A numerical rating scale (NRS) score at time zero (time of extubation).
Description
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
Time 0 (Time of Extubation)
Secondary Outcome Measure Information:
Title
Pain intensity expressed as A numerical rating scale (NRS) score at time 1 (time of delivery to Post Anesthesia Care Unit PACU).
Description
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
Time 1 (30 minutes after extubation in the Post Anesthesia Care Unit (PACU).
Title
Pain intensity expressed as A numerical rating scale (NRS) score at time 6 (6 hours postoperative).
Description
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
Time 6 (6 hours postoperative)
Title
Pain intensity expressed as A numerical rating scale (NRS) score at time 24 (24 hours postoperative).
Description
The numerical rating scale consists of a numeric version of the visual analogue scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. The numerical rating scale requires the patient to rate their pain on a defined scale. Numerical rating scale (NRS) is the simplest and most commonly used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
Time 24 (24 hours postoperative)
Title
Early ambulation.
Description
Time of starting ambulation postoperative
Time Frame
Time of ambulation during first 24 hours postoperative
Title
Time of first rescue analgesic.
Description
As-needed dose of opioid (morphine) to provide relief of first breakthrough pain.
Time Frame
During First 24 hours postoperative.
Title
Total dose of Postoperative morphine consumption during first 24 hours.
Description
Dose of morphine in milligram
Time Frame
During first 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diaaeldein Ibrahim, Lecturer
Phone
+201006516286
Email
diaaeldein@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams university hospitals
City
Cairo
State/Province
Al Abbassia
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diaaeldein M Haiba Ali Ibrahim, MD
Phone
+201006516286
Email
diaaeldein@med.asu.edu.eg

12. IPD Sharing Statement

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Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery

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