Effect of Regional Anesthesia on Enhanced Recovery After Spine Surgeries

NCT04586257 | Completed

• 1 other identifier: 34142/9/20
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be carried out on 80 patients who will be presented for different spine surgeries under general anesthesia and regional anesthesia technique in Tanta university hospitals. The study was approved by the research ethics committee of the faculty of medicine. Patients will be admitted to the OR where induction of general anesthesia was started and then, the patients will be randomly distributed into two equal groups; -

• Group I (40 patients) (ESP block): patients in this group will receive ESP block after induction of general anesthesia.
• Group II (40 patients) (TLIP block): patients in this group will receive TLIP block after induction of general anesthesia Measurements; - The length of hospital stay as the primary outcome Postoperative pain scores and opioid consumption as the Secondary outcome

Conditions

ERAS

Keywords

Spine surgery; Length of hospital stay; ERAS; Regional analgesia

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

  The time interval in days from the day of the surgery till discharge of the patient from the hospital.

  Within 7 days of the surgery

Secondary Outcomes (2)

• postoperative pain scores

  Within the first 24 hours after surgery

• The postoperative opioid consumption

  Within the first 24 hours after surgery

Study Arms (2)

Group I

EXPERIMENTAL

patients in this group will receive Erector spinae plane block after induction of general anesthesia.

Procedure: Erector spinae plane block

Group II

EXPERIMENTAL

patients in this group will receive thoracolumbar interfascial plane block after induction of general anesthesia

Procedure: Throacolumbar interfacial plane block

Interventions

Erector spinae plane block PROCEDURE

While patients in the prone position, 1.4-5.1 MHz low-frequency probe (C5-1s convex transducer) will be first placed in a longitudinal orientation in the midline to identify the spinous process of at the appropriate lumbar level, then it will be scanned laterally about 2-3 cm until visualization of the paraspinal muscles and the transverse process at the same time. After standard sterilization, a 21-G short bevel nerve block needle will be advanced in a cephalad-to-caudal direction, in-plane under real- time ultrasound guidance, through skin, subcutaneous tissue, and erector spinae muscles until reaching the transverse process. After negative aspiration of blood or cerebral spinal fluid, a small volume of local anesthetic was injected to confirm the position of the needle tip between the erector spinae muscles and the transverse process. A total of 20 ml of 0.0.25% plain bupivacaine will be incrementally injected with intermittent negative aspiration on each side.

Group I

Throacolumbar interfacial plane block PROCEDURE

USG-guided TLIP block will be performed using a high-frequency linear probe while the patient in prone position. The probe will be covered with sterile sheath positioned transversally in a midline position at approximately the level of the 3rd lumbar vertebra (L3). The corresponding spinous process and interspinal muscles will be identified, and the probe will be slid laterally to identify the multifidus (MF) muscle and longissimus (LG) muscle. Sliding the probe from midline to laterally helps in the correct identification of various muscles. After identifying the muscles, TLIP block will be performed aseptically on both sides of L3 vertebra. Under ultrasound guidance, an insulated echogenic needle will be inserted in-plane in a lateral to medial orientation in-plane USG guided through the belly of LG toward the MF. When needle reach deep to middle of MF/LG interface, 20 ml 0.25% bupivacaine will be injected after negative aspiration. The block will be administered bilaterally.

Group II

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for spine surgeries.

You may not qualify if:

• Patient refusal
• Body mass index (BMI) less than 18 or higher than35 kg/m2
• Pregnant
• History of relevant allergy to related perioperative medications
• Previous lumbar spine surgery
• Existing contraindications to nerve block such as coagulopathy, local and systemic infection
• Hepatic or renal insufficiency
• Chronic opioid use

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, Algharbia, 31511, Egypt

Location

Study Officials

• Sameh Abdelkhalik

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blinded to their groups. * An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: October 15, 2020
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
• Access Criteria: Contact the principal investigator

Locations

EG (1)