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Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery

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ClinicalTrials.gov Identifier: NCT02672813
Recruitment Status : Unknown
Verified February 2016 by Anuranjan Ghimire, B.P. Koirala Institute of Health Sciences.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Anuranjan Ghimire, B.P. Koirala Institute of Health Sciences

Brief Summary:
The primary objective of this study is to access the effect of Pectoral nerve I and II blocks in breast surgery as measured by consumption of postoperative morphine or its equivalent.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Pectoral nerve I and II block Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery: A Randomized Single Blinded Control Trial
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Pectoral Nerve I and II block
Under Ultrasound guidance, Pectoral nerve I block is given for every breast surgery using 10ml of 0.25 % Ropivacaine ( without added preservatives). Similarly Pectoral nerve II block is also given using 20 ml of 0.25% Ropivacaine ( without added preservative) in same group of patient.
Procedure: Pectoral nerve I and II block
Under Ultrasound guidance, Pectoral nerve I and II block is given for every breast surgery by using 10 and 20 ml of 0.25% Ropivacaine respectively
Other Name: Pecs block

No Intervention: No block
Pectoral nerve block is not given in this group of patients undergoing breast surgery



Primary Outcome Measures :
  1. Postoperative Morphine consumption. [ Time Frame: 24h ]
    Total amount of Morphine or its equivalent consumed by the patient in 24 hours following surgery is recorded


Secondary Outcome Measures :
  1. Postoperative Numerical Rating scale (NRS) score for pain [ Time Frame: 24 h ]
    NRS score for pain is used to assess the pain during rest , during coughing, and during abduction of ipsilateral shoulder within 24 hours following surgery at different time intervals

  2. Satisfaction level [ Time Frame: 24h ]
    Visual analog scale score for satisfaction level regarding the pain control after surgery is assessed at 24 hours of breast surgery

  3. Nausea and Vomiting [ Time Frame: 24h ]
    Number of patients who experience nausea and/or vomiting will be noted during the study

  4. Local Anesthetic toxicity [ Time Frame: 24h ]
    The occurrence of local anesthetic toxicity adverse reactions like pruritis, urticaria,headache, anxiety, confusion,tremors, tingling sensation, hypotension, cardiac arrhythmia, cardiac arrest, seizure will be noted and recorded during and after surgery.

  5. sedation score [ Time Frame: 24h ]
    5 point sedation scale is used to asses sedation within 24 hours at different time intervals ; where 0= alert, 1= arouses to voice, 2= arouses with gentle tactile stimulation, 3= arouses with vigorous tactile stimulation and 4= lack of responsiveness



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologist ( ASA) Physical Status I, II
  • Age between 16-65 Years
  • Patients Undergoing breast surgery

Exclusion Criteria:

  • Patient refusal
  • Local infection
  • Known hypersensitivity or any contraindications to study medication
  • History of chronic pain
  • Psychiatric illness
  • Bilateral breast surgery
  • Weight < 40 kg and > 100 kg

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): NCT02672813


Contacts
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Contact: Anuranjan Ghimire, MBBS 09779841551123 anuranjanghimire2@gmail.com
Contact: Krishna Pokharel, MD 09779841986321

Locations
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Nepal
BP Koirala Institute of Health Sciences Recruiting
Dharan, Sunsari, Nepal, 56700
Contact: Anuranjan Ghimire, MBBS    09779841551123    anuranjanghimire2@gmail.com   
Contact: Krishna Pokharel, MD    09779841986321      
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
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Study Director: Krishna Pokharel, MD BP Koirala Institute of Health Sciences

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Responsible Party: Anuranjan Ghimire, Resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT02672813     History of Changes
Other Study ID Numbers: IRC/521/015
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Anuranjan Ghimire, B.P. Koirala Institute of Health Sciences:
Pectoral nerve I and II blocks
Breast surgery
Ropivacaine
Postoperative opioid consumption

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