Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Jawaharlal Institute of Postgraduate Medical Education & Research

Status and phase: Completed; Phase 2

Conditions: Postoperative; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01454609

100745483-1910201028464726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

0.9% normal saline

Treatment:

Drug: 0.9% Normal saline

Bupivacaine

Experimental group

Description:

0.25% bupivacaine

Treatment:

Drug: Bupivacaine

Bupivacaine with clonidine

Experimental group

Description:

0.25% bupivacaine with 1 microgram/kg of clonidine

Treatment:

Device: Bupivacaine with clonidine (combination)