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NCT Number: NCT01454609

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Postoperative Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, 605013, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.9% normal saline

Drug

Saline

Other names: Saline

Bupivacaine

Drug

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

Bupivacaine with clonidine (combination)

Device

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)

Primary outcomes

  1. Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period

    Time frame: Intraoperative to 24 hours postoperative

Secondary outcomes

  1. Visual analog pain scores at specific time intervals

    Time frame: 24 hours postoperative

  2. Postoperative nausea and vomiting (PONV)and anti emetic requirements

    Time frame: 24 hours postoperative

  3. Side effects of the block, morphine and clonidine

    Time frame: 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2011
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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