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

November 10, 2024 updated by: Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center

A Controlled Study to Compare the Effect of Regional Anesthesia by an Erector Spine Plane Block and Intravenous Infusion of Lidocaine on the Rate of Intravenous Morphine Use After Scoliosis Repair Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. The opiate that is usually used after scoliosis repair surgery to correct scoliosis is morphine. It is given independently by the patients using the patient-controlled analgesia device. 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.

Patients will be randomized to one of 3 groups. The patients do not know which group they belong to.

Group C - control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study.

Group B - ESP block - patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. And then the anesthesiologist will perform an ultrasound-guided ESP block

Group L - Lidocaine - Patients will receive general anesthesia according to the standard protocol for general anesthesia for this study. In addition, after induction of anesthesia, patients will begin receiving an intravenous infusion of lidocaine and will continue to receive the infusion after surgery for a total of 24 hours.

The patients will be connected to the PCA device by the anesthetists before leaving for recovery unit. The patients will receive an explanation before and after the operation to press the PCA bolus only if there is strong bursting pain. 48 hours after the surgery, the PCA will be stopped and patients will receive other pain relievers as needed.

Patient report data on the level of pain and nausea will be collected 1, 6, 12, 24, and 48 hours after the end of the surgery. Data will also be collected on the maximum dose of morphine that the patient received from the PCA pump 24 and 48 hours after the end of the operation, the time of the first bowel movement and the time of the first walk, as well as demographic data of the patients. The QOR-15 questionnaire to check the quality of recovery will be filled out by the patients 72 hours after the end of the surgery

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel, 70300
        • Recruiting
        • Shamir (Asaf Harofe) Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yulya Godolov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Active Comparator: Erector spinae plane block
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
a local anesthetic drug of the amino amide type
Other Names:
  • Xylocaine
  • Lignocaine
Active Comparator: Lidocaine
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
a local anesthetic drug of the amino amide type
Other Names:
  • Xylocaine
  • Lignocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 48 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity,
Time Frame: 48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.
Monitoring the effect of treatments on pain intensity during the first 48 hours after surgery. Using patients' reported NRS scale 0-10 with 0 meaning no pain at all and 10 meaning the worst imaginable pain.
48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.
Quality of recovery
Time Frame: 72 hours after surgery
The patient will fill the QOR15 questionnaire for Quality of recovery
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: Sara Bar Yehuda, PhD, Shamir (Asaf Harofe) Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0008-24-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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