Does adding Magnesium Sulphate prolongs the Pain Relief after Leg Surgeries?

The Effects of Magnesium Sulphate as an Adjuvant to 0.5% Hyperbaric Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries:A Randomized Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073576

Enrollment

Registered

2024-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Magnesium Sulphate as an Adjuvant to 0.5% Hyperbaric Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries: A subarachnoid block is performed by an ex

Eligibility

Inclusion criteria

Inclusion criteria: 18-65 years of age of either sex, ASA I or II, scheduled for orthopedic lower limb surgeries for like Total knee replacement, Arthroscopy, Open reduction internal fixation for lower limb fractures etc., duration of surgery = 4hours.

Exclusion criteria

Exclusion criteria: Patient refusal, local site infection, pregnancy, mental illness, chronic liver and renal diseases, deranged coagulation profile, history of scorpion bite

Design outcomes

Primary

Measure	Time frame
1. To compare the duration of postoperative analgesia (defined as the time to first request for rescue analgesia) between the group receiving 50 mg intrathecal magnesium sulfate with a combination of 0.5% hyperbaric levobupivacaine and fentanyl and the control group receiving only the combination of 0.5% hyperbaric levobupivacaine and fentanyl. 2. To evaluate the time to achieve adequate sensory and motor block (onset time) following spinal anesthesia in both the magnesium sulfate and the control group.Timepoint: After subarachnoid block Baseline 2 min 4 min 6 min 8 min 10 min 12 min 14 min 16 min 18 min 20 min 35 min 50 min 65 min 80 min 95 min 110 min 125 min 185 min 245 min Post Operative Monitoring Baseline 30min 1 hr 2 hr 4 hr 8 hr 12 hr 18 hr 24 hr	—

Measure

Time frame

1. To compare the duration of postoperative analgesia (defined as the time to first request for rescue analgesia) between the group receiving 50 mg intrathecal magnesium sulfate with a combination of 0.5% hyperbaric levobupivacaine and fentanyl and the control group receiving only the combination of 0.5% hyperbaric levobupivacaine and fentanyl. 2. To evaluate the time to achieve adequate sensory and motor block (onset time) following spinal anesthesia in both the magnesium sulfate and the control group.Timepoint: After subarachnoid block Baseline 2 min 4 min 6 min 8 min 10 min 12 min 14 min 16 min 18 min 20 min 35 min 50 min 65 min 80 min 95 min 110 min 125 min 185 min 245 min Post Operative Monitoring Baseline 30min 1 hr 2 hr 4 hr 8 hr 12 hr 18 hr 24 hr

—

Secondary

Measure	Time frame
1. To assess postoperative rescue analgesic requirements in both groups. 2. To compare hemodynamic stability between the groups throughout the perioperative period. 3. To assess the incidence of side effects like hypotension, pruritis, shivering, nausea and vomiting.Timepoint: After subarachnoid block Baseline 2 min 4 min 6 min 8 min 10 min 12 min 14 min 16 min 18 min 20 min 35 min 50 min 65 min 80 min 95 min 110 min 125 min 185 min 245 min Post Operative Monitoring Baseline 30min 1 hr 2 hr 4 hr 8 hr 12 hr 18 hr 24 hr	—

Measure

Time frame

1. To assess postoperative rescue analgesic requirements in both groups. 2. To compare hemodynamic stability between the groups throughout the perioperative period. 3. To assess the incidence of side effects like hypotension, pruritis, shivering, nausea and vomiting.Timepoint: After subarachnoid block Baseline 2 min 4 min 6 min 8 min 10 min 12 min 14 min 16 min 18 min 20 min 35 min 50 min 65 min 80 min 95 min 110 min 125 min 185 min 245 min Post Operative Monitoring Baseline 30min 1 hr 2 hr 4 hr 8 hr 12 hr 18 hr 24 hr

—

Countries

India

Contacts

Public ContactPranita Mandal

All India Institute Of Medical Sciences, Bhopal

parinita08@gmail.com8800768428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026