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

NCT ID: NCT06451562

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-09-30

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.

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

Conditions

Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

a local anesthetic drug of the amino amide type

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

a local anesthetic drug of the amino amide type

Interventions

Lidocaine

a local anesthetic drug of the amino amide type

Intervention Type: DRUG

Other Intervention Names

Lignocaine; Xylocaine

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zoya Haitov Ben Zikri

Manager of the anesthesia unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Bar Yehuda, PhD

Role: STUDY_DIRECTOR

Shamir (Asaf Harofe) medical center

Locations

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sara Bar Yehuda, PhD

Role: CONTACT

sarabar1@shamir.gov.il

972528981004

Zoya Haitov Ben Zikri, MD

Role: CONTACT

ZoyaC@shamir.gov.il

972537346186

Facility Contacts

Sara Bar Yehuda, PhD

Role: primary

sarabar1@shamur.gov.il

972528981004

Zoya Haitov Ben Zikri

Role: backup

ZoyaC@shamir.gov.il

972537346186

Other Identifiers

0008-24-ASF

Identifier Type: -

Identifier Source: org_study_id