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Clinical Trials/NCT03947463
NCT03947463
Completed
Not Applicable

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

Shaukat Khanum Memorial Cancer Hospital & Research Centre1 site in 1 country120 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Regional Anesthesia
Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Enrollment
120
Locations
1
Primary Endpoint
Change in Pain score over 24 hours
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
March 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Responsible Party
Principal Investigator
Principal Investigator

Hammad Najeeb

Fellow in Anesthesia

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Pain score over 24 hours

Time Frame: First 24 hrs

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.

Secondary Outcomes

  • Post operative morphine (opioids) consumption in PACU(first 24 hours)
  • Antiemetic consumption for treatment of PONV(120 minutes)

Study Sites (1)

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