PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Status: Completed

Conditions: Cancer

Treatments: Procedure: regional block

Study type: Interventional

Funder types: Other

Identifiers

NCT07197177

IRB-21-22

Details and patient eligibility

About

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.

Full 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

Enrollment: 42 patients

Sex: All

Ages: Under 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy

Exclusion criteria

• . 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

42 participants in 2 patient groups

PECTORAL PLANE BLOCK

Experimental group

Description:

We will infiltrate local anesthesia in Pectoral Plane under ultrasound guidance.

Treatment:

Procedure: regional block

ERECTOR SPINAE PLANE BLOCK

Experimental group

Description:

We will infiltrate local anesthesia in ERECTOR spine Plane under ultrasound guidance.

Treatment:

Procedure: regional block