A clinical trial to study the effectiveness of pre-emptive tapentadol with block in patients undergoing breast surgery.
Not Applicable
Completed
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2020/09/027509
- Lead Sponsor
- nil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
Inclusion Criteria
1. Adult patients (Age >18 years and <65 years) with ASA I or II functional status undergoing MRM.
2. Patients who can understand and provide a valid consent for the procedure and also can understand and are willing to report the pain using VAS score.
Exclusion Criteria
Patients with
1.Chronic pain syndromes and on daily analgesics
2.Abnormal renal or liver function
3.Known psychiatric disorder receiving monoamine oxidase Inhibitors, tricyclic antidepressants or serotonin-norepinephrine reuptake inhibitors
4.COPD, asthma or other respiratory ailments
5.Infection at injection site
6.Bilateral breast surgeries
7.Opioid tolerance or dependence
8.Allergic to the study drug (tapentadol& bupivacaine)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare mean pain-free duration in patients receiving 100mg of extended-release (ER) preemptive tapentadol and in the control group following modified radical mastectomyTimepoint: 2hrs, 4hrs, 6hrs, 12hrs, 24hrs following surgery.
- Secondary Outcome Measures
Name Time Method 2.To compare the mean visual analog scale (VAS) score at 2hrs, 4hrs, 6hrs, 12hrs, and 24hrs <br/ ><br>3.To compare the total dose of rescue analgesia required in the first 24hrs <br/ ><br>4.To compare the total dose of intraoperative fentanyl used <br/ ><br>5.To assess the incidence of complications (postoperative retching, nausea, vomiting (PONV), pruritus and dizziness) in both groups in the first 24hrs <br/ ><br>Timepoint: 2.To compare the mean visual analog scale (VAS) score at 2hrs, 4hrs, 6hrs, 12hrs, and 24hrs <br/ ><br>3.To compare the total dose of rescue analgesia required in the first 24hrs <br/ ><br>4.To compare the total dose of intraoperative fentanyl used <br/ ><br>5.To assess the incidence of complications (postoperative retching, nausea, vomiting (PONV), pruritus and dizziness) in both groups in the first 24hrs <br/ ><br>