ScoliosisNCT06451562
Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery
A study testing Lidocaine in people with Scoliosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2024to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, 70300
Sara Bar Yehuda, PhD, 972528981004, sarabar1@shamur.gov.il
Zoya Haitov Ben Zikri, 972537346186, ZoyaC@shamir.gov.il
About this study
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
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lignocaine, Xylocaine
a local anesthetic drug of the amino amide type
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after surgery
Secondary outcomes (2)
Quality of recovery
The patient will fill the QOR15 questionnaire for Quality of recovery
Measured: 72 hours after surgery
Pain intensity,
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.
Measured: 48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center
- Investigators
- Sara Bar Yehuda, PhD, Study director, Shamir (Asaf Harofe) medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451562
- Sponsor's protocol ID
- 0008-24-ASF
- Status last verified
- Nov 2024
- First submitted
- 21 May 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No