Effect of Lidocaine Versus Magnesium on Postoperative Pain in Spine Surgery

August 22, 2022 updated by: Haitham Mohammad Ahmad Mohammad

Effect of Intravenous Single-bolus Lidocaine Infusion Versus Intravenous Single-bolus Magnesium Sulfate Infusion on Postoperative Pain, Emotional Status and Quality of Life in Patients Undergoing Spine Fusion Surgery

The goal in this work is to compare the effect of intravenous single-bolus lidocaine infusion versus intravenous single-bolus magnesium sulfate infusion on postoperative pain, emotional status and quality of life in patients undergoing spine fusion surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double-blinded prospective controlled randomized clinical trial that will be performed in Assiut university hospital.

After obtaining approval from Assiut University Hospital Ethical Committee and informed written consent from patients, this study will be conducted on ASA status I, II and III patients, aged between 18y and 60 y, both male and female, undergoing spinal fusion surgery (single, and double level).

Subjects will be excluded if they met any of the following criteria: Previous spine surgery, morbid obesity (BMI > 40), spine metastatic tumor, allergy to an amide LA, or magnesium sulfate, heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance , administration of any sedative, preexisting mental illness, psychological or emotional problems.

Randomization will be performed using lidocaine group, magnesium group, combined (lidocaine and magnesium) group and control group registers, which will be placed in sealed envelopes prior to study initiation, and opened prior to anesthesia by a physician who will prepare the IV solution, and identify it with the patient number, according to the envelope drawn. The solution will be handed to another physician, blind to the prepared solutions' content, who will be responsible for the anesthesia. The solution volume will be equal. The responsible investigator will remain blind to the chosen group until the end of the study.

Allocation concealment will be done using serially numbered closed, opaque envelopes. Each patient will be given a serial number from a computer-generated randomization table, and will be placed in the appropriate group after opening the corresponding sealed envelope. Counseling for participation will be conducted before recruitment.

Operative technique: Patients will be monitored with continuous electrocardiography, capnography, pulse oximetry, and intermittent non-invasive blood pressure measurements every 5 minutes.

After establishment of venous access, anesthesia will be induced with propofol 2 mg / kg, fentanyl 1.5 µg / kg and cisatracurium 0.15 mg/kg. Endotracheal tube of appropriate size will be inserted and mechanical ventilation utilizing isoflurane in oxygen/air mixture at sufficient concentration to maintain systolic blood pressure within the limit of 20% baseline value.

All patients will receive 30 mg ketorolac IV infusion after induction of anesthesia, Paracetamol 1g will be given by IV infusion to all patients before extubation. Reversal of residual muscle relaxant will be accomplished using neostigmine, and atropine at the end of the operation guided by train of four.

Intraoperative fluid therapy will be administered in the form of normal saline after calculation of fasting and maintenance fluid requirements.

Patients will be discharged to PACU then to the ward after fulfilling the standard criteria.

No other anesthetics or sedatives will be allowed during the operation. In the first 24 hours postoperative; patients will be given Ketorolac 30 mg slowly IV (diluted to 10 ml) every 12h, and paracetamol 1g injection every 8 hours; starting 8 hours after extubation. Morphine 0.1mg/kg slowly IV will be given as rescue analgesia when numeric rating scale (NRS) is ≥4, or if the patient requested additional analgesia, with a minimum 8 hours interval between the 2 consecutive injections. Total doses of IV morphine will be documented.

After 24 hours post-operation; paracetamol 1 g every 8 hours will be given orally for 5 days. Ketolac 30 mg will be given orally only if needed.

Pain will be assessed during rest and cough in the first 24 h, and during movement after 24h. postoperative.

All patients will be urged to ambulate as early as practically possible. Collected data will include patient's characteristics, and surgical data including age, gender, weight, height, duration of surgery, and duration of hospital stay. Postoperative pain evaluation during rest will be assessed by numeric rating scale (NRS). Patients' satisfaction will be assessed by using 5 points Likert score for satisfaction where 1=strongly dissatisfied; 2=Dissatisfied; 3=neither satisfied nor dissatisfied; 4=Satisfied; 5=strongly satisfied. The two scores will be recorded at the following times: immediately at 1 h; 6 h; 12 h; 24 h; at discharge time; 1 month; 2 months, and 3 months postoperative.

Time to the first request for analgesia and the total dose of rescue analgesia (morphine) in the first 24 hours after surgery will be recorded. The long-term follow-up of postoperative back pain for 3 months will be conducted through the outpatient orthopedic clinic, or by telephone.

Hemodynamics and blood loss will be reported First time to pass flatus, first time to defecate and incidence of complications will also be reported (such as hypotension, bradycardia, anxiety, dizziness, muscle twitching, nervousness, reaction at the site of injection, cardiac arrest, double vision, nausea, seizures, unconsciousness, euphoria, tinnitus, vomiting).

Testing for gross mental and neurologic defects will be performed with the Mini-Mental Status Examination, which has a standard scoring method with a maximum score of 30. The total duration of the testing will not exceed 45 minutes. Interruptions will be allowed at the request of the patient between, but not within, individual tests of the session. The tests will be administered by the same examiner to limit interexaminer variability.

The anxiety and depression status will be evaluated by Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and QOL will be measured by Short Form Health Survey 36 (SF-36) in eight sections, including vitality, physical functioning, bodily pain, general health perceptions, mental health, physical, emotional, and social role functioning.

The study portion of the tests will be performed at least 6 hours after the initial intravenous bolus of drugs, while the control portion will be performed at least 24 hours after the studied drugs are discontinued. Tests will be repeated after 1 week and 4 weeks.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA status I, II and III patients
  • Age 18 - 60 y
  • Gender: both male and female
  • Undergoing spinal fusion surgery (single, and double level).

Exclusion Criteria:

  • Previous spine surgery
  • Morbid obesity (BMI > 40)
  • Spine metastatic tumor
  • Allergy to an amide LA, or magnesium sulfate
  • Heart block, renal, or liver dysfunction
  • Substance abuse disorder, or chronic opioid use, administration of any sedative or preexisting mental illness.
  • Electrolyte disturbance.
  • Psychological or emotional problems.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine group
30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.
Drug: Lidocaine IV
single-bolus of lidocaine IV 4 mg/kg
Drug: IV saline
Saline IV 50 ml
Active Comparator: Magnesium group
30 patients will receive IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.
Drug: IV saline
Saline IV 50 ml
Drug: Magnesium Sulfate Injection
single-bolus of magnesium sulfate IV 30 mg / kg
Active Comparator: Combination group
30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. after induction of anesthesia.
Drug: Lidocaine IV
single-bolus of lidocaine IV 4 mg/kg
Drug: Magnesium Sulfate Injection
single-bolus of magnesium sulfate IV 30 mg / kg
Placebo Comparator: control group
30 patients will receive IV saline 50 ml plus IV saline 50 ml over 30 min. after induction of anesthesia.
Drug: IV saline
Saline IV 50 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short-term postoperative pain control
Time Frame: first 24 hours postoperative (Day 0)
Short-term pain control will be assessed in the first 24 hours postoperative. by numeric rating scale (NRS). It ranges from 0 to 10 where 0= no pain and 10= maximum pain
first 24 hours postoperative (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term pain control
Time Frame: Every month till 3 months (Month 1, Month 2, Month 3)
long-term pain control will be assessed by numeric rating scale (NRS), It ranges from 0 to 10 where 0= no pain and 10= maximum pain
Every month till 3 months (Month 1, Month 2, Month 3)
Total opioid consumption
Time Frame: Every month till 3 months (Month 1, Month 2, Month 3)
Total opioid consumption will be calculated
Every month till 3 months (Month 1, Month 2, Month 3)
Mental state, Anxiety and depression , quality of life
Time Frame: 6 hours postoperative, 24 hours postoperative, 1 week postoperative, 4 weeks postoperative
Mini-mental state scale, Self-rating anxiety scale (SAS), Self-rating depression scale (SDS) and short form health survey 36 scale(SF-36).
6 hours postoperative, 24 hours postoperative, 1 week postoperative, 4 weeks postoperative

Collaborators and Investigators

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

Sponsor

Haitham Mohammad Ahmad Mohammad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pain after spine fusion

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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