Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Pain Clinical Trial

Official title:

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454609
• Other study ID #: 100745483-1910201028464726
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2011
• Last updated: October 18, 2011
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2011
• Source: Jawaharlal Institute of Postgraduate Medical Education & Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Postoperative

Intervention

Drug:
• 0.9% Normal saline
Saline
• Bupivacaine
Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours

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

Locations

Country	Name	City	State
India	Jawaharlal Institute of Postgraduate Medical Education and Research	Pondicherry

Sponsors (1)

Lead Sponsor	Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period		Intraoperative to 24 hours postoperative	Yes
Secondary	Visual analog pain scores at specific time intervals		24 hours postoperative	Yes
Secondary	Postoperative nausea and vomiting (PONV)and anti emetic requirements		24 hours postoperative	Yes
Secondary	Side effects of the block, morphine and clonidine		24 hours postoperative	Yes