A study to compare postoperative analgesia in patients undergoing modified radical mastectomy under epidural ropivacaine alone or using butorphanol versus fentanyl as adjuvant to ropivacaine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Duration Of Postoperative Analgesia
Study Overview
Brief Summary
The aim of this study is to compare the pain relief and complications after epidural administration of ropivacaine or ropivacaine–butorphenol or ropivacaine-fentanyl or complications arising due to the procedure itself, in patients undergoing Modified Radical Mastectomy(MRM). The study will be conducted on 90 females undergoing Modified Radical Mastectomy will be divided into 3 groups with 30 patients each. Group A will be given ropivacaine 0.25% 6ml with 2 ml of normal saline through epidural route; Group B will receive 6ml of 0.25% ropivacaine with butorphanol 1ml (1mg/ml) and 1 ml normal saline through epidural route.; Group C will receive 6ml of 0.25% ropivacaine with 2 ml fentanyl (100 micrograms) through epidural route. The postoperative analgesia will be given as epidural top-ups in the form of ropivacaine(0.125% 6ml) and the data from the above study will be systematically collected, compiled and statistically analyzed to draw relevant conclusions.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA grade 1 & 2.
Exclusion Criteria
- •Patients having bleeding diathesis
- •Patients on any anticoagulant therapy
- •Patients with known hypersensitivity to local anaesthetics or study drugs.
- •Patient suffering from uncontrolled asthma, cardiac, respiratory, renal, thyroid, hepatic and CNS disorders.
- •Patients with local sepsis or spinal deformity.
Outcomes
Primary Outcomes
Duration Of Postoperative Analgesia
Time Frame: Duration Of Analgesia From Drug Administration To VAS Equals To Or More Than 4 in Postoperative Period In First 24 Hours
Secondary Outcomes
- 1.Intraoperative Haemodyanamic Stability(2.Total Dose Of Postoperative Analgesic Requirement)