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The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248179
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax - but hypothetically without the risks of adverse events associated with the TPVB (i.e. pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable epidural spread etc.). The investigators have already tested the anatomical- and block execution hypothesis in a randomized cadaveric study, and the investigators now have anatomical proof of concept for the functionality of the block technique. The investigators have also conducted a small clinical pilot study with very promising results. The investigators wish to conduct a randomized, placebo controlled and double-blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. The aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer or ductal carcinoma in situ. The hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects.

Condition or disease Intervention/treatment Phase
Breast Cancer Ductal Carcinoma in Situ Drug: Ropivacaine injection Drug: Saline 0.9% Drug: Sufentanil and PONV prophylaxis Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery. A Double Blind, Randomised, Placebo Controlled Trial.
Actual Study Start Date : November 29, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Ropivacaine 5mg/ml corresponding to 3 * 10ml * 5mg/ml Ropivacaine = 150mg Ropivacaine.
Drug: Ropivacaine injection
Ropivacaine 5mg/ml

Drug: Sufentanil and PONV prophylaxis
30 minutes prior to emergence 0.2 μg/kg total body weight Sufentanil IV and 1 gram of paracetamol IV (if 6hrs since preoperative medicine) and 4 mg ondansetron IV (PONV prophylaxis) will be administered.
Other Name: For postoperative pain and PONV treatment in the PACU

Placebo Comparator: Placebo
Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Sodium chloride 9mg/ml corresponding to 3 * 10ml * 9mg/ml Sodium chloride = 189mg Sodium chloride.
Drug: Saline 0.9%
Saline 0.9%

Drug: Sufentanil and PONV prophylaxis
30 minutes prior to emergence 0.2 μg/kg total body weight Sufentanil IV and 1 gram of paracetamol IV (if 6hrs since preoperative medicine) and 4 mg ondansetron IV (PONV prophylaxis) will be administered.
Other Name: For postoperative pain and PONV treatment in the PACU




Primary Outcome Measures :
  1. Morphine Consumption [ Time Frame: 24 hours ]
    The primary aim of this study is total morphine consumption in the first 24 postoperative hours (data from PCA pump and the patient's medical record).


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 24 hours ]

    Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15 minutes, 30 minutes, 45 minutes and one hour.

    And pain intensity (NRS 0-10/10) in the intervals

    • [ arrival at the ward - 4 hrs. postop ]
    • ] 4 hrs. postop - 8 hrs. postop ]
    • ] 8 hrs. postop - 12 hrs. postop ]
    • ] 12 hrs. postop - 16 hrs. postop ]
    • ] 16 hrs. postop - 20 hrs. postop ]
    • ] 20 hrs. postop - 24 hrs. postop ]

  2. Morphine consumption at 4, 8, 12, 16 and 20 postoperative hours. [ Time Frame: 20 hours ]
    NRS score will be recorded electronically in the PCA-pump when morphine is administrated. All patients must enter NRS 0-10 on the PCA pump prior to morphine bolus administration.

  3. Duration of block (time to first opioid). [ Time Frame: 24 hours ]
    How long time does the MICB work?

  4. Patient satisfaction with application of the block. [ Time Frame: Immediately after application ]
    Patient is asked immediately after block application, Numeric Rating Scale (0-10, 0 = no pain, 10 = worst pain)

  5. The degree of morphine-related side effects (PONV, itching, fatigue, etc.). [ Time Frame: 24 hours ]
    PONV. 0-3; 0=No nausea. 3=Unmanageable nausea

  6. Time from operation (T0) to ambulation (bed to chair to walking) [ Time Frame: 24 hours ]
    When is the patient capable to ambulate; ie. going to the bathroom by themself

  7. Time to discharge (days). [ Time Frame: 5 days (anticipated) ]
    When is the patient discharged?

  8. Quality of recovery [ Time Frame: 24 hours and 14 days ]
    Quality of Recovery - 15 score (QoR15). Preoperatively compared to twice postoperatively. Preoperatively the patients are asked to fill in the validated Quality of Recovery Questionnaire QoR1536 questionnaire repeated at T0+24hrs. and 14 days after surgery (possibly by phone interview). The QoR15 questionnaire results in a score of 0-150.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for elective unilateral mastectomy and primary reconstructive (UMPR) surgery with subpectoral implant due to breast cancer and ductal carcinoma in situ
  • Age 18 years or above at the date of inclusion
  • Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the study.

Exclusion Criteria:

  • Scheduled for elective UMPR surgery due to breast cancer and DCIS combined with simultaneous contralateral major breast surgery* (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted.
  • Scheduled free flap reconstructive surgery
  • Inability to cooperate
  • Inability to speak, read and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids, according to the investigators decision
  • Illegal drug and/or substance abuse, according to the investigators decision
  • Local infection at the site of injection or systemic infection
  • Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution
  • Substantial co-morbidity, ASA>3
  • Severe hypovolemia
  • Pregnant or breastfeeding

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): NCT04248179


Contacts
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Contact: Martin V Nielsen, MD +4521234956 martinvedel@gmail.com
Contact: Jens N Børglum, PhD, MD +4530700120 jens.borglum@gmail.com

Locations
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Denmark
Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde Recruiting
Roskilde, Zealand Region, Denmark, 4000
Contact: Martin V Nielsen, MD    +4521234956    martinvedel@gmail.com   
Contact: Jens N Børglum, PhD, MD    +4530700120    jens.borglum@gmail.com   
Sponsors and Collaborators
Zealand University Hospital
Copenhagen University Hospital, Denmark
Investigators
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Study Director: Jens N Børglum, PhD, MD Department of Anaesthesiology, Zealand University Hospital, Roskilde
Publications:
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04248179    
Other Study ID Numbers: ZUH-MICB-UMPR
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zealand University Hospital:
Postoperative Pain
Opioid Consumption
Ultrasound guided nerve block
Paravertebral Block by proxy
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Sufentanil
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General