Trial | NCT01454609  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Jan 31
2009
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Oct 19
2011
Estimate

Drug 0.9% Normal saline

Saline

  • Other names: Saline

Drug Bupivacaine

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

  • Other names: Marcaine, Sensoricaine

Device Bupivacaine 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

  • Other names: Marcaine (for bupivacaine), Sensoricaine (for bupivacaine)

Saline Placebo Comparator

0.9% normal saline

Bupivacaine Experimental

0.25% bupivacaine

Bupivacaine with clonidine Experimental

0.25% bupivacaine with 1 microgram/kg of clonidine

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.
No Results Posted