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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454609

Enrollment

Registered

2011-10-19

Start date

2009-01-31

Completion date

2010-07-31

Last updated

2011-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

cervical plexus block, thyroidectomy, postoperative analgesia

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.

Interventions

DRUG0.9% Normal saline

Saline

DRUGBupivacaine

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

DEVICEBupivacaine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026