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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01454609 |
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Date of registration:
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08/10/2011 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
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Scientific title:
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Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01454609 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Sarath Chandra Sistla, MS(Surgery) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor, Dept. of Surgery, JIPMER |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Consenting consecutive euthyroid patients undergoing elective thyroidectomy under
general anesthesia, of either genders and more than 18 years of age, belonging to the
ASA class I and II.
Exclusion Criteria:
- Patients unable to understand visual analog pain score (VAS) or unable to use patient
controlled analgesia (PCA).
- Patients with malignancy requiring block dissection or with substernal goiters -
Contraindications to superficial cervical plexus block like allergy to local
anesthetics, bleeding diatheses and local infection or sepsis.
- Contraindications to morphine like bronchial asthma and hypothyroidism.
- Sensitivity to the anesthetic agent used or intolerance to the medications used in
the study.
- Patients who received steroids or opioids or other analgesics recently.
- Patients with history of stridor.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Postoperative
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Intervention(s)
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Device: Bupivacaine with clonidine (combination)
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Drug: 0.9% Normal saline
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Drug: Bupivacaine
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Primary Outcome(s)
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Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
[Time Frame: Intraoperative to 24 hours postoperative]
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Secondary Outcome(s)
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Postoperative nausea and vomiting (PONV)and anti emetic requirements
[Time Frame: 24 hours postoperative]
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Side effects of the block, morphine and clonidine
[Time Frame: 24 hours postoperative]
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Visual analog pain scores at specific time intervals
[Time Frame: 24 hours postoperative]
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Secondary ID(s)
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100745483-1910201028464726
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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