Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karthikeyan V S, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier:
NCT01454609
First received: October 8, 2011
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Pain
Postoperative
Drug: 0.9% Normal saline
Drug: Bupivacaine
Device: Bupivacaine with clonidine (combination)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jawaharlal Institute of Postgraduate Medical Education & Research:

Primary Outcome Measures:
  • Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period [ Time Frame: Intraoperative to 24 hours postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual analog pain scores at specific time intervals [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
  • Postoperative nausea and vomiting (PONV)and anti emetic requirements [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
  • Side effects of the block, morphine and clonidine [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
0.9% normal saline
Drug: 0.9% Normal saline
Saline
Other Name: Saline
Experimental: Bupivacaine
0.25% bupivacaine
Drug: Bupivacaine
Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
Other Names:
  • Marcaine
  • Sensoricaine
Experimental: Bupivacaine with clonidine
0.25% bupivacaine with 1 microgram/kg of clonidine
Device: Bupivacaine with clonidine (combination)

Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours

Clonidine - 0.5 - 1 microgram/ kg

Other Names:
  • Marcaine (for bupivacaine)
  • Sensoricaine (for bupivacaine)

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01454609

Locations
India
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry, India, 605013
Sponsors and Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators
Study Chair: Sarath Chandra Sistla, MS(Surgery) Professor, Dept. of Surgery, JIPMER
  More Information

No publications provided

Responsible Party: Karthikeyan V S, Senior Resident, Urology, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier: NCT01454609     History of Changes
Other Study ID Numbers: 100745483-1910201028464726
Study First Received: October 8, 2011
Last Updated: October 18, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Jawaharlal Institute of Postgraduate Medical Education & Research:
cervical plexus block
thyroidectomy
postoperative analgesia

Additional relevant MeSH terms:
Bupivacaine
Clonidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics

ClinicalTrials.gov processed this record on July 23, 2014