Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

NCT01454609 | Completed Phase 2 DMC

• 1 other identifier: 100745483-1910201028464726
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervical plexus block; thyroidectomy; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period

  Intraoperative to 24 hours postoperative

Secondary Outcomes (3)

• Visual analog pain scores at specific time intervals

  24 hours postoperative

• Postoperative nausea and vomiting (PONV)and anti emetic requirements

  24 hours postoperative

• Side effects of the block, morphine and clonidine

  24 hours postoperative

Study Arms (3)

Saline

PLACEBO COMPARATOR

0.9% normal saline

Drug: 0.9% Normal saline

Bupivacaine

EXPERIMENTAL

0.25% bupivacaine

Drug: Bupivacaine

Bupivacaine with clonidine

EXPERIMENTAL

0.25% bupivacaine with 1 microgram/kg of clonidine

Device: Bupivacaine with clonidine (combination)

Interventions

0.9% Normal saline DRUG

Saline

Also known as: Saline

Saline

Bupivacaine DRUG

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

Also known as: Marcaine, Sensoricaine

Bupivacaine

Bupivacaine with clonidine (combination) 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

Also known as: Marcaine (for bupivacaine), Sensoricaine (for bupivacaine)

Bupivacaine with clonidine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jawaharlal Institute of Postgraduate Medical Education & Research: lead

Study Sites (1)

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, 605013, India

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution; Sodium Chloride; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sarath Chandra Sistla, MS(Surgery)

  Professor, Dept. of Surgery, JIPMER

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Urology

Study Record Dates

• First Submitted: October 8, 2011
• First Posted: October 19, 2011
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

IN (1)