A Randomized Clinical Trial

Study Overview
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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.

Official Title
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Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomies A Randomized Clinical Trial

Conditions
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Regional Anesthesia

Intervention / Treatment
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* Procedure: PECS block


Participation Criteria
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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: Patient's refusal history of allergy to bupivacaine contraindications to regional anaesthesia (coagulopathy and local infection), BMI > 40 kg/m2, patient scheduled for bilateral mastectomies use of chronic pain medications history of illicit drugs or alcohol abuse and history of psychiatric problems.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PECS block group<br>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 | Procedure: PECS block<br>* 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.<br>|
| No Intervention: Control group<br>Patient were given multimodal analgesia without the regional block | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain score over 24 hours | Patient's pain intensity was assessed using NPRS (Numeric Pain scoring system). Pain score was assessed at the time of arrival at PACU (0 minute) and then at 30 minutes after surgery and at discharge from PACU. Pain score was then assessed at the surgical floor at 6hours, 12hours and 24hours. | First 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative morphine (opioids) consumption in PACU | If the NPRS score was 3 or more, rescue analgesic dose of 1.5 mg of morphine was administered slowly through the IV route and the pain score was reassessed after 15 minutes. If the pain score was still more than 3, additional dose of 1.5 mg morphine was given. This cycle continued till pain resolved. | first 24 hours | 
| Antiemetic consumption for treatment of PONV | The incidence of PONV was assessed using a 5-point scale (4-0), where 4 was equivalent to vomiting more than once, 3 was equivalent to one episode of vomit, 2 was equivalent to severe nausea, 1 was equivalent to mild nausea and 0 being no nausea. If the PONV score was more than 2, ondansetron 2 mg IV was administered to treat nausea and vomiting | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pectoral Nerves I & II block, Serratus Plane Block, General Anesthesia, opioid analgesia, breast cancer and modified radical mastectomy