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A clinical trial to evaluate the efficacy of wound instillation with ropivacine with fentanyl or dexmedetomidine or morphine for post operative analgesia in patients undergoing mastectomy.

To evaluate the efficacy of instillation of ropivacaine with fentanyl or dexmedetomidine or morphine through surgical drains for post operative analgesia in patients undergoing mastectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028900
Enrollment
75
Registered
2020-11-04
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: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: wound instillation with local anaesthetics through surgical drain: wound instillation with 40 ml 0.25 % ropivacaine with 4.5 mg morphine ( frequency: Single Dose ) through surgically pl

Sponsors

PT BD SHARMA PGIMS ROHTAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult female patients Age between 30-70 years ASA Physical Status Class I & II scheduled for mastectomy with axillary clearance.

Exclusion criteria

Exclusion criteria: Patients with uncontrolled cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric diseases or diabetes mellitus; major blood loss during surgery or continued excessive blood collection in to the drains and having allergy to the study drugs.

Design outcomes

Primary

MeasureTime frame
1 Pain Score 2 Duration of analgesia 3 Need for rescue analgesia 4 Side effects if anyTimepoint: Intra operative and 24 hour post operative period

Secondary

MeasureTime frame
Heart rate Blood pressure Spo2 Visual Analogue Score at Rest Visual Analogue Score on movementTimepoint: Intra operative and 24 hour post operative period

Countries

India

Contacts

Public ContactDr Naveen Malhotra

Pt BD SHARMA PGIMS ROHTAK

sanjays321@yahoo.co.in9416050652

Outcome results

None listed

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