Comparison of Effectiveness of Ultrasound Guided Erector Spinae Plane Block With Ultrasound Guided Serratus Anterior Block in Modified Radical Mastectomy, Randomized Single Blinded Comparative Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total amount of postoperative morphine consumption in 24 hours. (mg)
Study Overview
Brief Summary
The aim of this study is to compare and evaluate the safety and analgesic efficacy of ultrasound guided ESP block and ultrasound guided serratus anterior plane block in patients undergoing modified radical mastectomy.
Detailed Description
Methodology:
This Randomised Comparative Single Blinded Study was conducted at National Cancer Institute Cairo University after approval by the institutional review board, scientific committee of Anesthesia department Kasr Alainy Cairo University (02/10/2019 Code: N - 65\2019 ms) and Ethical committee at Kasr Alainy Cairo University (1\ 12 \2019 code: MS-268-2019)
Type of consent of study participants: Written and verbal
Study Methods:
Population of study: 60 Female patients ASA II, III scheduled for modified radical mastectomy under general anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
Performer of nerve blocks will know type of block but investigator for postoperative pain will be blinded
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female patients
- •Type of surgery; Modified Radical Mastectomy MRM
- •Physical status ASA II, III.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
Exclusion Criteria
- •Age: ≤18 years or ≥65 years
- •BMI: ≤20 kg/m2 or ≥ 35 kg/m2
- •Known sensitivity or contraindication to drugs used in the study (local anaesthetics, opioids).
- •History of psychological disorders and/or chronic pain syndrome.
- •Contraindication to regional anaesthesia e.g. local sepsis, pre-existing peripheral neuropathies and coagulopathy.
- •Patient refusal.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Pregnancy.
- •Physical status ASA IV
- •Male patients.
Outcomes
Primary Outcomes
Total amount of postoperative morphine consumption in 24 hours. (mg)
Time Frame: 24 hours
Total amount of postoperative morphine consumption in 24 hours. (mg)
Secondary Outcomes
- Numeric Pain Rating Scale score, both at rest and during movement(24 hours)
- Block related complications(24 hours)
- Patient satisfaction(24 hours)
- Change in mean arterial blood pressure intraoperatively(duration of surgery)
- Total amount of intraoperative fentanyl consumption (mcg)(duration of surgery)
- Change in heart rate intraoperatively(duration of surgery)
- The degree of postoperative sedation according to Ramsay scores.(24 hours)
- Time to first rescue analgesia (hours)(postoperative)
Investigators
Mohammed Magdy Abdelrahman Elsayed
Resident of Anaesthesiology, ICU and Pain Management
National Cancer Institute, Egypt