Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Phase 2

Completed

• Conditions: Pain; Postoperative
• Interventions: Drug: 0.9% Normal saline; Device: Bupivacaine with clonidine (combination); Drug: Bupivacaine

• Registration Number: NCT01454609
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

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.

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-10
• Study First Submitted: 2011-10-08
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-19
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	0.9% Normal saline	0.9% normal saline
Bupivacaine with clonidine	Bupivacaine with clonidine (combination)	0.25% bupivacaine with 1 microgram/kg of clonidine
Bupivacaine	Bupivacaine	0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period	Intraoperative to 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research; 🇮🇳 Pondicherry, India