PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL
- Conditions
- Cancer
- Registration Number
- NCT07197177
- Lead Sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Brief Summary
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group.
- Detailed Description
This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy
- . Exclusion criteria included patient refusal to participate, age less than 18 years, diagnosed allergy or contraindication to local anesthetic, chronic pain, obesity (BMI >35), non-cancerous or undiagnosed breast lesions, ASA IV status, and emergency surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean Morphine consumption 12 hours calculate morphine consumption intraoperatively and post operative at 12 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Skmch & Rc
🇵🇰Lahore, Punjab Province, Pakistan
Skmch & Rc🇵🇰Lahore, Punjab Province, Pakistan