Thoracolumbar Interfascial Plane Block in Lumber Spine Surgery

NCT05880017 | Unknown

• 1 other identifier: FMASU R 167/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain Management

Keywords

Thoracolumber; Interfascial plane; Lumber discectomy

Outcome Measures

Primary Outcomes (1)

• 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."

  Time 0 (Time of Extubation)

Secondary Outcomes (6)

• Pain intensity expressed as A numerical rating scale (NRS) score at time 1 (time of delivery to Post Anesthesia Care Unit PACU).

  Time 1 (30 minutes after extubation in the Post Anesthesia Care Unit (PACU).

• Pain intensity expressed as A numerical rating scale (NRS) score at time 6 (6 hours postoperative).

  Time 6 (6 hours postoperative)

• Pain intensity expressed as A numerical rating scale (NRS) score at time 24 (24 hours postoperative).

  Time 24 (24 hours postoperative)

• Early ambulation.

  Time of ambulation during first 24 hours postoperative

• Time of first rescue analgesic.

  During First 24 hours postoperative.

Study Arms (3)

Modified Group

ACTIVE COMPARATOR

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

Procedure: Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block.; Drug: Bupivacain

Conventional Group

ACTIVE COMPARATOR

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

Procedure: Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block.; Drug: Bupivacain

Morphine Group

ACTIVE COMPARATOR

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

Drug: Morphine for peritoperative analgesia (control group).

Interventions

Modified ultrasound guided thoracolumbar interfascial plane (TLIP) block. 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.

Modified Group

Conventional ultrasound guided thoracolumbar interfascial plane (TLIP) block. 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.

Conventional Group

Morphine for peritoperative analgesia (control group). 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.

Morphine Group

Bupivacain DRUG

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

Conventional Group; Modified Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, Al Abbassia, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Dental Occlusion; Morphine; Control Groups; Bupivacaine

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Diaaeldein Ibrahim, Lecturer

CONTACT

+201006516286; diaaeldein@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain management

Model Details: Prospective , randomized controlled, comparative study.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

EG (1)