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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2021-12-25

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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PECTORAL PLANE BLOCK

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

Group Type EXPERIMENTAL

regional block

Intervention Type PROCEDURE

We will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay.

ERECTOR SPINAE PLANE BLOCK

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

Group Type EXPERIMENTAL

regional block

Intervention Type PROCEDURE

We will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay.

Interventions

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regional block

We will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay.

Intervention Type PROCEDURE