Clinical trial NCT01454609: Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Official title: Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Postoperative
Keywords: cervical plexus block
thyroidectomy
postoperative analgesia
Lead sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
Sponsor class: OTHER_GOV
First posted: 2011-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
timeFrame: Intraoperative to 24 hours postoperative
Secondary outcomes:
measure: Visual analog pain scores at specific time intervals
timeFrame: 24 hours postoperative
measure: Postoperative nausea and vomiting (PONV)and anti emetic requirements
timeFrame: 24 hours postoperative
measure: Side effects of the block, morphine and clonidine
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Pondicherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
Study officials:
affiliation: Professor, Dept. of Surgery, JIPMER
name: Sarath Chandra Sistla, MS(Surgery)
role: STUDY_CHAIR
References: