Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery

NCT06451562 | Recruiting

• 1 other identifier: 0008-24-ASF
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease. After scoliosis surgery, patients experience severe pain. The standard treatment for pain relief after scoliosis surgery is the administration of opiates. However, treatment with these substances involves side effects such as respiratory depression, nausea and vomiting, inhibition of bowel activity and itching. To lower the dose of opiates, different types of painkillers and other techniques can be added. The purpose of the study is to compare the effect of instillation of lidocaine (which is an analgesic and anti-inflammatory) or regional anesthesia using Erector spinae plane on the dose of morphine consumption, the intensity of pain, the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Dosage of morphine consumption in milligrams that the patients will consume in by pressing on the PCA device in the first 48 hours after surgery to correct scoliosis

  48 hours after surgery

Secondary Outcomes (2)

• Quality of recovery

  72 hours after surgery

• Pain intensity,

  48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.

Study Arms (3)

Control

NO INTERVENTION

This group will serve as a control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. Upon the end of the surgery, patients will begin receiving analgesics and anti-nausea treatment according to the standard protocol in this study.

Erector spinae plane block

ACTIVE COMPARATOR

Patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. After induction for anesthesia, before the start of the surgery, the anesthesiologist will perform an ultrasound guided ESP block, according to the ultrasound guided erector spinae plane block protocol

Drug: Lidocaine

Lidocaine

ACTIVE COMPARATOR

Patients will receive general anesthesia according to the standard general anesthesia protocol for this study. In addition, after induction of anesthesia, patients will begin receiving an intravenous infusion of lidocaine at a dose of 0.5 mg per kg per hour, and will continue to receive the infusion after surgery for a total of 24 hours.

Drug: Lidocaine

Interventions

Lidocaine DRUG

a local anesthetic drug of the amino amide type

Also known as: Lignocaine, Xylocaine

Erector spinae plane block; Lidocaine

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients over the age of 12 with normal cognition, who are scheduled to undergo surgery to correct scoliosis and treatment with IV PCA independently for pain relief after surgery; The patients' parents/guardian (in the case of a minor) or the patient himself (in the case of an adult) signed an informed consent form for participation in the study; Patients should be able to operate the PCA device independently

You may not qualify if:

• Patients who do not agree to participate in the study even if their parents signed an informed consent
• Patients who are unable to operate the PCA device independently
• Patients under treatment with opioids or cannabis for chronic pain for more than a month;
• Drug use of any kind;
• Alcoholism;
• Patients with depression, anxiety or post-trauma;
• Moderate-severe insufficiency of one of the systems - respiratory/cardiac/hepatic/renal;
• Sensitivity to one of the drugs in the research protocol.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sara Bar Yehuda, PhD

  Shamir (Asaf Harofe) medical center

  STUDY DIRECTOR

Central Study Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004; sarabar1@shamir.gov.il

Zoya Haitov Ben Zikri, MD

CONTACT

972537346186; ZoyaC@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of the anesthesia unit

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 11, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)