Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946294
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Khaled Mostafa Kamel, Cairo University

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine 0.25% with epinephrine Phase 2

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2016
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: modified pectoral nerves block
Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.
Drug: Bupivacaine 0.25% with epinephrine
Other Name: Markyrene

Active Comparator: serratus plane block
Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.
Drug: Bupivacaine 0.25% with epinephrine
Other Name: Markyrene




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946294


Locations
Layout table for location information
Egypt
National Cancer Institute
Cairo, Misr Al Qadimah, Egypt, 11796
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Ayman A Ghoneim, MD National Cancer Institute, Cairo University
Study Chair: Ahmad H Aboul Soud, MD National Cancer Institute, Cairo University
Principal Investigator: Khaled M Salem, Master National Cancer Institute, Cairo University
Principal Investigator: Mohamed E Hassan, MD National Cancer Institute, Cairo University
Principal Investigator: Ahmad H Mohamed, MD National Cancer Institute, Cairo University

Publications:

Layout table for additonal information
Responsible Party: Khaled Mostafa Kamel, Assistant Lecturer of Anesthesia and Pain Relief, Cairo University
ClinicalTrials.gov Identifier: NCT02946294     History of Changes
Other Study ID Numbers: MD2010014055.3
IRB00004025 ( Other Identifier: Institutional Review Board )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents