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A clinical study to evaluate effectiveness of drug tramadol for pain free period after gynecological surgeries

Comparison of sensory blockade and duration of post operative analgesic effect between bupivacaine heavy and bupivacaine heavy plus tramadol intrathecally in patients undergoing gynecological surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027221
Enrollment
40
Registered
2020-08-18
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: N80-N98- Noninflammatory disorders of female genital tract

Interventions

Intervention1: Post operative analgesic effect of Bupivacaine heavy 3ml that is 15mg plus tramadol 0.5 ml that is 25mg INTRATHECALLY in spinal anaesthesia: Post operative analgesic effect of Bupivacai

Sponsors

Shree krishna hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1-3 physical status

Exclusion criteria

Exclusion criteria: Hypersensitivity to local anesthetics, absolute contraindications to spinal anesthesia that is patients refusal, any bleeding diathesis patients, local site infection,relative contraindications like severe hypotension, obstructive cardiomyopathies, any spinal deformity, spinal cord injnury

Design outcomes

Primary

MeasureTime frame
Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement.Timepoint: Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement.—

Secondary

MeasureTime frame
Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY.Timepoint: Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY.—

Countries

India

Contacts

Public ContactParth B Bhatt

Pramukh Swami Medical College Shree Krishna Hospital

docbhum29@yahoo.com9904438877

Outcome results

None listed

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