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Does addition of Tramadol Ropivacaine increase the anaesthetic duration for femur surgeries?

Intrathecal Ropivacaine versus Intrathecal Ropivacaine and Tramadol for Lower Limb Orthopaedic Surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003344
Enrollment
60
Registered
2013-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Adult males with unilateral femur fractures Health Condition 2: S720- Fracture of head and neck of femur

Interventions

Intervention1: Combined spinal and Epidural Block: Combined spinal and epidural block will be given in two different spaces using the minipak and 25 G spinal needle and ropivacaine 2.5 ml with normal

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male patients with femur fractures, who belong to ASA class I or II and are between 18-60 years of age will be recruited for the study.

Exclusion criteria

Exclusion criteria: Patients with a known hypersensitivity to any of the drugs, bilateral lower limb fractures, contraindications to regional anaesthesia, gross spinal deformity, emergency surgery and peripheral neuropathy will be excluded from the study. Patients with height less than 150 cm or more than 180 cm will also be excluded.

Design outcomes

Primary

MeasureTime frame
1. To study the sensory and motor block of intrathecal ropivacaine with or without the addition of tramadol. 2. To compare the time to achieve maximum sensory and motor block. Timepoint: 2,4,6,8,10,15,20,25,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240,255,270 minutes after giving the subarachnoid block

Secondary

MeasureTime frame
To compare the duration of sensory block. To compare the degree of sedation in the two groups. To compare the side effects like nausea, vomiting, hypotension, shivering, pruritus in the two groups. Timepoint: 0,2,6,8,10,15,20,25,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240,265,270 minutes after giving the spinal anaesthesia

Countries

India

Contacts

Public ContactDr Rashmi Salhotra

UCMS and GTB Hospital, Delhi

rashmichabra@yahoo.com9911317334

Outcome results

None listed

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