Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative
• Intervention / Treatment: Drug: 0.9% Normal saline; Drug: Bupivacaine; Device: Bupivacaine with clonidine (combination)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Pondicherry, India, 605013
    • Jawaharlal Institute Of Postgraduate Medical Education And Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; 0.9% normal saline	Drug: 0.9% Normal saline; Saline; Other Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period	Intraoperative to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
• Investigators: Study Chair: Sarath Chandra Sistla, MS(Surgery), Professor, Dept. of Surgery, JIPMER

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 8, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): October 19, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: thyroidectomy; postoperative analgesia; cervical plexus block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympatholytics; Bupivacaine; Clonidine
• Other Study ID Numbers: 100745483-1910201028464726