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.
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2020/11/028900
- Lead Sponsor
- PT BD SHARMA PGIMS ROHTAK
- Brief Summary
There are many studies on wound instillation with ropivacaine andbupivacaine, that has produced promising results in postoperative pain management.But few studies have been done to evaluate the efficacy of instillation ofropivacaine with fentanyl or dexmedetomidine or morphine in surgical field forpostoperative analgesia. Therefore we propose to conduct this study to evaluatethe efficacy of instillation of ropivacaine with fentanyl or dexmedetomidine ormorphine through surgical drains for post operative analgesia in patientsundergoing mastectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 75
Adult female patients Age between 30-70 years ASA Physical Status Class I & II scheduled for mastectomy with axillary clearance.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Pain Score Intra operative and 24 hour post operative period 2 Duration of analgesia Intra operative and 24 hour post operative period 3 Need for rescue analgesia Intra operative and 24 hour post operative period 4 Side effects if any Intra operative and 24 hour post operative period
- Secondary Outcome Measures
Name Time Method Heart rate Blood pressure Spo2 Visual Analogue Score at Rest
Trial Locations
- Locations (1)
Pt BD Sharma PGIMS
🇮🇳Rohtak, HARYANA, India
Pt BD Sharma PGIMS🇮🇳Rohtak, HARYANA, IndiaDr Sumit PG Student Department of AnaesthesiologyPrincipal investigator8447094050sumitdas211@gmail.com