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Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Information source: Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Postoperative

Intervention: 0.9% Normal saline (Drug); Bupivacaine (Drug); Bupivacaine with clonidine (combination) (Device)

Phase: Phase 2

Status: Completed

Sponsored by: Jawaharlal Institute of Postgraduate Medical Education & Research

Official(s) and/or principal investigator(s):
Sarath Chandra Sistla, MS(Surgery), Study Chair, Affiliation: Professor, Dept. of Surgery, JIPMER


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Visual analog pain scores at specific time intervals

Postoperative nausea and vomiting (PONV)and anti emetic requirements

Side effects of the block, morphine and clonidine

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.


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 605013, India
Additional Information

Starting date: January 2009
Last updated: October 18, 2011

Page last updated: August 23, 2015

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