Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Analgesia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 64 years
Gender
Both males and females

Description

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome. Morphine administration for acute pain after mastectom...

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties. The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects. As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.

Tracking Information

NCT #
NCT04531215
Collaborators
Not Provided
Investigators
Study Chair: Alshaimaa Kamel, M.D Zagazig University