Comparison between two adjuvants used in Spinal Anaesthesia in patients undergoing lower limb orthopaedic surgeries

A double blinded randomized controlled trial for comparing Dexamethasone and Dexmedetomidine when added to intrathecal hyperbaric (0.5%) Bupivacaine in elective lower limb orthopaedic surgeries - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062984

Enrollment

Registered

2024-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Procedure - Spinal anaesthesia Drug - Injection Hyperbaric bupivacaine (0.5%) and dexmedetomidine.: The patients will receive Spinal anaesthesia with 2.5 ml of 0.5% hyperbaric bupivaca

Eligibility

Inclusion criteria

Inclusion criteria: 1. patients undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia 2. patients who have given written informed consent to participate in the study 3. ASA grade 1 and 2

Exclusion criteria

Exclusion criteria: 1. Patient with any contraindication to spinal anaesthesia 2. Patients with known allergies to the drugs used 3. Infection at the site of injection 4. Coagulopathy, any coagulopathy disorder or patients on anti-coagulants 5. Pre-existing neurological disease, psychological trouble, endocrinal disease 6. Morbid obesity 7. failure of spinal blockade 8.Patients with previous spinal surgery, kyphoscoliosis or any spinal deformity 9.Pregnancy 10. Patient undergone any other clinical trial within 03 months 11.Patients having hypersensitivity to the drugs used in study 12. History of any any neurological disease like GB Syndrome, subacute combined degeneration of spinal cord

Design outcomes

Primary

Measure	Time frame
To compare the depth of analgesia between the two groups of adjuvant drugs given in spinal anaesthesia (using Visual Analogue Scale score for pain) with intrathecal Bupivacaine 0.5% plus DEXMEDETOMIDINE vs. intrathecal Bupivacaine 0.5% plus DEXAMETHASONE in post-operative period in elective lower limb orthopaedic surgery.Timepoint: visual analogue scale score for pain will be used to measure pain postoperatively every 15 minute interval for first 240 minutes then every hourly for next 480 minutes	—

Measure

Time frame

To compare the depth of analgesia between the two groups of adjuvant drugs given in spinal anaesthesia (using Visual Analogue Scale score for pain) with intrathecal Bupivacaine 0.5% plus DEXMEDETOMIDINE vs. intrathecal Bupivacaine 0.5% plus DEXAMETHASONE in post-operative period in elective lower limb orthopaedic surgery.Timepoint: visual analogue scale score for pain will be used to measure pain postoperatively every 15 minute interval for first 240 minutes then every hourly for next 480 minutes

—

Secondary

Measure	Time frame
to compare side effects between the two groups of adjuvant drugs in spinal anaesthesia with injection hyperbaric Bupivacaine with Dexamethasone versus Injection hyperbaric Bupivacaine with injection Dexmedetomidine in patients undergoing lower limb orthopaedic surgeriesTimepoint: monitoring for side effects will be done post operatively every 15 minutes for first 240 minutes & then every hourly for next 480 minutes	—

Measure

Time frame

to compare side effects between the two groups of adjuvant drugs in spinal anaesthesia with injection hyperbaric Bupivacaine with Dexamethasone versus Injection hyperbaric Bupivacaine with injection Dexmedetomidine in patients undergoing lower limb orthopaedic surgeriesTimepoint: monitoring for side effects will be done post operatively every 15 minutes for first 240 minutes & then every hourly for next 480 minutes

—

Countries

India

Contacts

Public ContactProfessor Subrata Kumar Mandal

College Of Medicine and Sagore Dutta Hospital

drsubrata2010@gmail.com9433175801

Outcome results

None listed

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