Clinical trial NCT06451562: Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-06-11
Enrollment: 105
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Morphine consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Quality of recovery
timeFrame: 72 hours after surgery
measure: Pain intensity,
timeFrame: 48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir (Asaf Harofe) Medical Center
Study officials:
affiliation: Shamir (Asaf Harofe) medical center
name: Sara Bar Yehuda, PhD
role: STUDY_DIRECTOR
References: