MedDataX Logo

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

NCT ID: NCT01454609

Last Updated: 2011-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline

0.9% normal saline

Group Type PLACEBO_COMPARATOR

0.9% Normal saline

Intervention Type DRUG

Saline

Bupivacaine

0.25% bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

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

Bupivacaine with clonidine

0.25% bupivacaine with 1 microgram/kg of clonidine

Group Type EXPERIMENTAL

Bupivacaine with clonidine (combination)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.9% Normal saline

Saline

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Saline Marcaine Sensoricaine Marcaine (for bupivacaine) Sensoricaine (for bupivacaine)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karthikeyan V S

Senior Resident, Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarath Chandra Sistla, MS(Surgery)

Role: STUDY_CHAIR

Professor, Dept. of Surgery, JIPMER

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

100745483-1910201028464726

Identifier Type: -

Identifier Source: org_study_id