To study the effectiveness of magnesium sulphate in the management of pain after a multilevel posterior spinal surgery , when the drug is injected into the veins by means of an electronic device which functions on patient demand.

Phase 1

Recruiting

• Conditions: Other osteoporosis without currentpathological fracture,

• Registration Number: CTRI/2019/11/022185
• Lead Sponsor: christian medical college vellore

Brief Summary

Management of post operative pain is challenging. Posterior spine fusion surgeries require high quality analgesia to maximize functional recovery . Adequate post-operative analgesia helps with early mobilisation, brief hospital stay, reduced hospital costs and increased patient comfort. Magnesium sulphate through NMDA receptor blockade in the central nervous system and calcium channel blockade has been reported to be an effective anesthetic adjunct for pain relief and also in blunting somatic , autonomic and endocrine reflexes induced by noxious stimuli. Magnesium sulphate has been used in the form of bolus and /or continuous intravenous infusions intra-operatively and has been found to attenuate acute post-operative pain in total knee arthroplasty. In this randomized control trial , we aim to assess the efficacy of magnesium sulphate as an additive in intravenous patient controlled analgesia (PCA) for post operative pain management ,in patients undergoing multilevel posterior spinal surgeries between the age of 18-65 years. The participants are randomized into **two study groups** - group 1 receiving PCA fentanyl and ketamine and group 2 receiving PCA fentanyl ,ketamine and magnesium .Postoperatively the pain scores will be assessed at specified time intervals as specified in the attached sheet. Vitals , sedation score ,nausea ,vomiting and quality of sleep will be monitored regularly in the ward. Number of boluses delivered to each participant will be noted 24 hours after surgery .**Serum magnesium levels will be checked pre operatively and at 24 ,48 hours after starting the PCA infusion . Magnesium toxicity will be monitored by regular assessment of knee jerk, urine output and respiratory rate**. Participants will be followed up at 3 months of surgery for the assessment of chronic pain relief.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-12
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1.patients undergoing multilevel posterior spinal fusion 2.ASA I and II 3.Age between 18-65 years 4.GFR (glomerular filtration rate ) >90ml/min/1.73m2.

Exclusion Criteria

• ASA III and IV 2.
• GFR <90ml/min/1.73m2 3.
• Patients diagnosed with hypermagnesemia 4.
• Chronic opioid use 5.
• Allergy to study drugs 6.
• Inability to use PCA pumps.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post operative pain score at rest and on movement.	post operative pain score at rest and on movement at 0,6,12,24,36 and 48 hours.

Secondary Outcome Measures

Name	Time	Method
number of boluses administered at end of 24 hours,assessment of quality of sleep,post operative nausea and vomiting,sedation scores,chronic pain assessment.	0,6,12,24,36,48 hours and 3 months

Trial Locations

Locations (1)

christian medical college vellore; 🇮🇳 Vellore, TAMIL NADU, India

christian medical college vellore

🇮🇳Vellore, TAMIL NADU, India

Dr Shalaka Ashok Tembhurne

Principal investigator

9423668845

shalaka.abc@gmail.com