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Pectoral Nerve Blockade in Mastectomy

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ClinicalTrials.gov Identifier: NCT01943240
Recruitment Status : Withdrawn (Insufficient population of eligible patients; none enrolled)
First Posted : September 16, 2013
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Timothy R Petersen, University of New Mexico

Brief Summary:
Our routine practice for patients undergoing mastectomy is to include paravertebral peripheral nerve blockade for postoperative analgesia. This study investigates whether the addition of another nerve block targeting the pectoral nerves will improve that analgesia.

Condition or disease Intervention/treatment Phase
Postoperative Pain Breast Cancer Drug: Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels Drug: 10 cc of 0.375% ropivacaine pectoral nerve block Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Analgesia With Addition of Pectoral Nerve Block to Thoracic Paravertebral Blocks in Unilateral Total Simple Mastectomy
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Group A
Paravertebral peripheral nerve blockade with with 4 mL of 0.5% ropivacaine at each of six levels, plus 10 cc of 0.375% ropivacaine for pectoral nerve block
Drug: Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels
Drug: 10 cc of 0.375% ropivacaine pectoral nerve block
Active Comparator: Group S
Paravertebral peripheral nerve blockade with 4 mL of 0.5% ropivacaine at each of six levels, plus 10 cc of normal saline for pectoral nerve block.
Drug: Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels



Primary Outcome Measures :
  1. Total opioid consumption in post anesthesia care unit (PACU) [ Time Frame: Up to 8 hours ]

Secondary Outcome Measures :
  1. Maximum pain score in PACU (numerical rating scale) [ Time Frame: Up to 8 hours ]
  2. Time to meet PACU discharge criteria [ Time Frame: Up to 8 hours ]
  3. Patient satisfaction with block [ Time Frame: 1 day ]
  4. Postoperative nausea and vomiting (PONV) [ Time Frame: Up to 8 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years and older
  • Able to provide own consent
  • Simple mastectomy at University of New Mexico Hospital without planned axillary surgery

Exclusion Criteria:

  • Spinal deformity or pathology
  • Chest wall deformity or pathology
  • BMI >40
  • Bilateral simple mastectomy
  • Refusal of regional anesthesia
  • Chronic pain
  • History of recent drug or alcohol abuse
  • History of recent psychiatric problems
  • Allergies to lidocaine or ropivacaine
  • Allergies to fentanyl or hydromorphone
  • Surgery that extends beyond the original plan to include axillary exposure

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): NCT01943240


Locations
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United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
Timothy R Petersen
Investigators
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Principal Investigator: Nicholas Lam, MD University of New Mexico

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Responsible Party: Timothy R Petersen, Research Information Specialist, University of New Mexico
ClinicalTrials.gov Identifier: NCT01943240     History of Changes
Other Study ID Numbers: Pec block
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents