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Completed

NCT Number: NCT03947463

A Randomized Clinical Trial

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.

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Key information

Conditions

Regional Anesthesia Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PECS block

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.

Primary outcomes

  1. 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

  1. Post operative morphine (opioids) consumption in PACU

    Time frame: first 24 hours

    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.

  2. Antiemetic consumption for treatment of PONV

    Time frame: 120 minutes

    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

Sponsors and collaborators

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 13, 2019
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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