Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Jawaharlal Institute of Postgraduate Medical Education & Research60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Postoperative

Interventions

0.9% Normal salineDRUG

Saline

BupivacaineDRUG

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 (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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Intraoperative to 24 hours postoperative

Secondary Outcomes

Visual analog pain scores at specific time intervals

Time frame: 24 hours postoperative

Postoperative nausea and vomiting (PONV)and anti emetic requirements

Time frame: 24 hours postoperative

Side effects of the block, morphine and clonidine

Time frame: 24 hours postoperative

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes