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Completed

NCT Number: NCT02946294

Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Institute

Cairo, Misr Al Qadimah, 11796, Egypt

About this study

This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).

Exclusion criteria

  • Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.

Treatment and study plan

Bupivacaine 0.25% with epinephrine

Drug

Other names: Markyrene

Primary outcomes

  1. Fentanyl consumption

    Time frame: Intraoperative

  2. Total morphine consumption

    Time frame: The first 24 hours postoperative

  3. Visual analogue scale score at rest and during shoulder movement

    Time frame: The first 24 hours postoperative

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative

    Hemodynamics

  2. Heart rate

    Time frame: Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative

    Hemodynamics

  3. Time to first requirement of rescue analgesia

    Time frame: The first 24 hours postoperative

  4. Sedation score

    Time frame: Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative

    as a side effect of morphine

  5. Respiratory rate

    Time frame: Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative

    respiratory depression defined as respiratory rate <12 breaths per minute

  6. Nausea and vomiting

    Time frame: The first 24 hours postoperative

    as a side effect of morphine

  7. Patient satisfaction with postoperative analgesia

    Time frame: One week after surgery

    using numerical rating scale from 0 to 10

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2016
Registry last updated
Dec 13, 2017

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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