A Randomized Clinical Trial

NCT ID: NCT03947463

Last Updated: 2019-05-13

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-03-01

Brief Summary

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Acute postoperative pain is a common problem faced by the patient after surgery, most frequently occurring in first 24 hours. Our primary objective was to assess pain score in first 24 hours in PECS block group undergoing mastectomies. Secondary objective was to observe morphine (opioids) and antiemetic consumption in post anesthetic care unit.

Detailed Description

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Design: Observer Blinded Randomized control trial.

Place and Duration: Department of Anesthesiology, Shaukat Khanum Memorial Cancer Hospital Lahore (SKMCH), from February 2017 to December 2017

Methods: 120 patients more than 18 years, ASA I and II, planned for unilateral elective modified radical mastectomy under general anesthesia were randomly assigned to receive either general anesthesia plus Pectoral Nerve I, II and serratus (PECS) block (n = 60) or general anesthesia alone (n = 60). Pain score at fixed intervals was measured using Numeric Pain Rating Score (NPRS) after surgery.

Conditions

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Regional Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Registered pain nurse

Study Groups

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PECS block group

20ml of 0.25% bupivacaine was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualised on the ultrasound screen. similarly, in Serratus plane block, ultrasound probe was placed over the mid-axillary region of the thoracic cage in a sagittal plane. Ribs were identified inferiorly and laterally, until the identification of the 3rd rib in the mid axillary line. 10 ml of 0.25% bupivacaine was infiltrated in between Serratus anterior muscle and Latissimus Dorsi muscle

Group Type EXPERIMENTAL

PECS block

Intervention Type PROCEDURE

After the induction of general anesthesia, PECS block was administered patients via ultrasound guided technique. We used Mindray M7 Portable ultrasound system using linear probe with (5-10 MHz) frequency. After cleaning the infra clavicular and axillary region with 2% chlorhexidine in 70% Alcohol solution, ultrasound probe was placed in the infraclavicular region and pectoral major and minor were identified. After identification of the landmarks, 20 gauge 50mm Visoplex needle was inserted in-plane direction. 20ml of 0.25% bupivacaine (within the safe limit of its dose) was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualized on the ultrasound screen.

Control group

Patient were given multimodal analgesia without the regional block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PECS block

After the induction of general anesthesia, PECS block was administered patients via ultrasound guided technique. We used Mindray M7 Portable ultrasound system using linear probe with (5-10 MHz) frequency. After cleaning the infra clavicular and axillary region with 2% chlorhexidine in 70% Alcohol solution, ultrasound probe was placed in the infraclavicular region and pectoral major and minor were identified. After identification of the landmarks, 20 gauge 50mm Visoplex needle was inserted in-plane direction. 20ml of 0.25% bupivacaine (within the safe limit of its dose) was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualized on the ultrasound screen.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female age 18 or older
* (ASA) I and II
* Scheduled to undergo elective unilateral mastectomy or Modified radical mastectomy (MRM) under general anesthesia.

Exclusion Criteria

1. Patient's refusal
2. history of allergy to bupivacaine
3. contraindications to regional anaesthesia (coagulopathy and local infection),
4. BMI \> 40 kg/m2,
5. patient scheduled for bilateral mastectomies
6. use of chronic pain medications
7. history of illicit drugs or alcohol abuse and history of psychiatric problems.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaukat Khanum Memorial Cancer Hospital & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Hammad Najeeb

Fellow in Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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IRB-15-03

Identifier Type: -

Identifier Source: org_study_id

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