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Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

NCT01454609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-10-19

No results posted yet for this study

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.

Conditions

  • Pain
  • Postoperative

Interventions

DRUG

0.9% Normal saline

Saline

DRUG

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

Sponsors & Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    lead OTHER_GOV

Principal Investigators

  • Sarath Chandra Sistla, MS(Surgery) · Professor, Dept. of Surgery, JIPMER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454609 on ClinicalTrials.gov