A study to compare the efficacy of addition of dexamethasone to regular epidural bupivacaine in prolongation of duration of pain relief in patients who undergo lower limb bone surgeries

Comparative study to assess the duration of post Operative analgesia using epidural bolus of bupivacaine Versus bupivacaine with dexamethasone in orthopaedic Lower limb surgeries under combined spinal epidural Anaesthesia :a randomized controlled trial - NILL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088647

Enrollment

100

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: M966- Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate

Interventions

Intervention1: Epidural administration of Inj Bupivacaine and Dexamethasone: Participants in this group will receive an epidural injection (a type of pain-relieving injection given in the lower back)

Eligibility

Inclusion criteria

Inclusion criteria: Patients posted for elective lower limb orthopaedic surgery 18 60 years of age ASA physical status I,II

Exclusion criteria

Exclusion criteria: Known allergy to bupivacaine and dexamethasone Patient refusal Patients with severe cardiovascular disease Pregnant and lactating women Infection at the injection site or epidural space Coagulation disorders Previous lumbar spine surgery Increased intracranial pressure

Design outcomes

Primary

Measure	Time frame
To compare the duration of postoperative analgesia achieved with an epidural bolus of bupivacaine versus a combination of bupivacaine with dexamethasone in patients undergoing orthopaedic lower limb surgeries under combined spinal-epidural anaesthesia.Timepoint: Baseline 15 mins 30 mins 45 mins 60 mins 75 mins 90 mins 105 mins 120 mins 150 mins 180 mins	—

Secondary

Measure	Time frame
To assess postoperative pain intensity using Visual Analog Scale in both groups.Timepoint: At 1 hour after epidural bolus At 2 hours At 4 hours At 6 hours At 12 hours At 24 hours At 48 hours (optional, depending on expected duration of analgesia)	—

Countries

India

Contacts

Public ContactDR SAVITHA V

ESIC Medical College and Hospital

savitha.velss@gmail.com9789308406

Outcome results

None listed

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