Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Information source: Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Postoperative
Intervention: 0.9% Normal saline (Drug); Bupivacaine (Drug); Bupivacaine with clonidine (combination) (Device)
Phase: Phase 2
Status: Completed
Sponsored by: Jawaharlal Institute of Postgraduate Medical Education & Research Official(s) and/or principal investigator(s): Sarath Chandra Sistla, MS(Surgery), Study Chair, Affiliation: Professor, Dept. of Surgery, JIPMER
Summary
With thyroid surgery being performed as an ambulatory procedure, most recent studies
concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral
superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep
cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence
the investigators compared the efficacy of BSCPB with 0. 25% bupivacaine with or without
clonidine in thyroidectomy, as preemptive analgesia.
The hypothesis was bupivacaine with the addition of clonidine would help in reducing
postoperative pain and thereby reduce the need for postoperative analgesia.
Clinical Details
Official title: Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
Secondary outcome: Visual analog pain scores at specific time intervalsPostoperative nausea and vomiting (PONV)and anti emetic requirements Side effects of the block, morphine and clonidine
Detailed description:
To find out if addition of BSCPB to general anesthesia with bupivacaine with or without
clonidine prolongs the time needed for postoperative analgesic and facilitate to perform
thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea
and vomiting.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 605013, India
Additional Information
Starting date: January 2009
Last updated: October 18, 2011
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