Effect of Lidocaine Versus Magnesium on Postoperative Pain in Spine Surgery

NCT04776369 | Unknown Phase 4

• 1 other identifier: Pain after spine fusion
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• short-term postoperative pain control

  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 Outcomes (3)

• long-term pain control

  Every month till 3 months (Month 1, Month 2, Month 3)

• Total opioid consumption

  Every month till 3 months (Month 1, Month 2, Month 3)

• Mental state, Anxiety and depression , quality of life

  6 hours postoperative, 24 hours postoperative, 1 week postoperative, 4 weeks postoperative

Study Arms (4)

Lidocaine group

ACTIVE COMPARATOR

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; Drug: IV saline

Magnesium group

ACTIVE COMPARATOR

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: Magnesium Sulfate Injection; Drug: IV saline

Combination group

ACTIVE COMPARATOR

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; Drug: Magnesium Sulfate Injection

control group

PLACEBO COMPARATOR

30 patients will receive IV saline 50 ml plus IV saline 50 ml over 30 min. after induction of anesthesia.

Drug: IV saline

Interventions

Lidocaine IV DRUG

single-bolus of lidocaine IV 4 mg/kg

Combination group; Lidocaine group

Magnesium Sulfate Injection DRUG

single-bolus of magnesium sulfate IV 30 mg / kg

Combination group; Magnesium group

IV saline DRUG

Saline IV 50 ml

Lidocaine group; Magnesium group; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haitham Mohammad Ahmad Mohammad: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (8)

• Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.

  PMID: 23121612 RESULT

• Amir R, Argoff CE, Bennett GJ, Cummins TR, Durieux ME, Gerner P, Gold MS, Porreca F, Strichartz GR. The role of sodium channels in chronic inflammatory and neuropathic pain. J Pain. 2006 May;7(5 Suppl 3):S1-29. doi: 10.1016/j.jpain.2006.01.444.

  PMID: 16632328 RESULT

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 RESULT

• Dunn LK, Yerra S, Fang S, Hanak MF, Leibowitz MK, Tsang S, Durieux ME, Nemergut EC, Naik BI. Incidence and Risk Factors for Chronic Postoperative Opioid Use After Major Spine Surgery: A Cross-Sectional Study With Longitudinal Outcome. Anesth Analg. 2018 Jul;127(1):247-254. doi: 10.1213/ANE.0000000000003338.

  PMID: 29570151 RESULT

• Gupta K, Vohra V, Sood J. The role of magnesium as an adjuvant during general anaesthesia. Anaesthesia. 2006 Nov;61(11):1058-63. doi: 10.1111/j.1365-2044.2006.04801.x.

  PMID: 17042843 RESULT

• Kosharskyy B, Almonte W, Shaparin N, Pappagallo M, Smith H. Intravenous infusions in chronic pain management. Pain Physician. 2013 May-Jun;16(3):231-49.

  PMID: 23703410 RESULT

• Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.

  PMID: 24216403 RESULT

• Lenart MJ, Wong K, Gupta RK, Mercaldo ND, Schildcrout JS, Michaels D, Malchow RJ. The impact of peripheral nerve techniques on hospital stay following major orthopedic surgery. Pain Med. 2012 Jun;13(6):828-34. doi: 10.1111/j.1526-4637.2012.01363.x. Epub 2012 Apr 11.

  PMID: 22494645 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be randomly assigned to 4 groups: * Group A: 30 patients will receive IV lidocaine 4 mg/kg (Tan, 2019) in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia. * Group B: 30 patients will receive IV magnesium sulfate 30mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia. * Group C: 30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV magnesium sulfate 30mg/kg in 50 ml volume over 30 min. after induction of anesthesia. * Group D (control group): 30 patients will receive IV saline 50 ml plus IV saline 50 ml over 30 min. after induction of anesthesia.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)