Effectiveness of Adding Magnesium Sulphate to Epidural Bupivacaine and Morphine for Pain Relief After Lower Limb Orthopedic Surgery

EFFICACY OF EPIDURAL MAGNESIUM SULPHATE AS ADJUVANT TO BUPIVACAINE-MORPHINE VERSUS BUPIVACAINE MORPHINE ALONE FOR POSTOPERATIVE ANALGESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100018

Enrollment

Registered

2026-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: T07- Unspecified multiple injuries

Interventions

Intervention1: EPIDURAL ANALGESIA: Under proper antiseptic precaution and patient in sitting position Epidural catheter will be inserted through 18Gauze Tuohy needle at L1-L2 OR L2-L3 BASED ON THE SU

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 18-65 years of age Patients who are classified under ASA Physical status ASA I and II Patients undergoing elective lower limb orthopedic surgeries

Exclusion criteria

Exclusion criteria: Patients with known hypersensitivity to magnesium sulphate. Any contraindications for Central neuraxial blocks Patients with Renal or Hepatic dysfunction Patients with 2nd and 3rd degree atrio ventricular blocks Patients who are on opioid or calcium channel blocker Patients with history of bleeding disorders Patients with neurological and psychiatric illness. Patients with Obstructive sleep apnea [OSA] Patients with Body Mass Index [BMI] more than 35 Patients with Chronic Obstructive Pulmonary Disease [COPD]

Design outcomes

Primary

Measure	Time frame
To compare the duration and quality of postoperative analgesia between the two groups (Bupivacaine + Morphine + Magnesium vs Bupivacaine and Morphine alone) as measured by visual analogue scale (VAS).Timepoint: At 2nd hour,4th hour,8th hour, 12th hour and 24 hours post operatively	—

Secondary

Measure	Time frame
To assess and compare the incidence of opioid related side effects such as nausea, vomiting, bradycardia, hypotension, pruritus and respiratory depression. To compare the total rescue analgesia required within 24 hours post operatively between the two groups. To compare the time to first rescue analgesia requirement in both the groups To evaluate the patient satisfaction level. To compare perioperative inflammatory response between the two groups by measuring [IL-6, CRP, TNF-alpha] Timepoint: at 2nd 4th 8th 12th and 24 hour post operatively ,inflammatory markers will be seen samples collected on day of surgery pre operatively and post operative samples will be collected 12-24 hours post surgery	—

Measure

Time frame

To assess and compare the incidence of opioid related side effects such as nausea, vomiting, bradycardia, hypotension, pruritus and respiratory depression. To compare the total rescue analgesia required within 24 hours post operatively between the two groups. To compare the time to first rescue analgesia requirement in both the groups To evaluate the patient satisfaction level. To compare perioperative inflammatory response between the two groups by measuring [IL-6, CRP, TNF-alpha] Timepoint: at 2nd 4th 8th 12th and 24 hour post operatively ,inflammatory markers will be seen samples collected on day of surgery pre operatively and post operative samples will be collected 12-24 hours post surgery

—

Countries

India

Contacts

Public ContactARVIND N

SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

gayathrii.r@gmail.com9500092905

Outcome results

None listed

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