Comparison of the efficacy of three different formulations of local anaesthetics during thyroid surgery

Completed

• Conditions: Posted for thyroid surgeries

• Registration Number: CTRI/2011/09/001998

Brief Summary

**Objective:** To compare the efficacy and safety of local anaesthetics using lidocaine (1%), bupivacaine (0.25%) and ropivacaine (0.5%) under cervical epidural anaesthesia (CEA) for thyroid surgery.xml:namespace prefix = o /

**Material and Methods:** In a prospective, randomized fashion, 81 cases were selected for thyroid surgery under CEA. They were assigned to one of three groups: group L, B &R to receive 10 ml of 1% lidocaine; 0.25% bupivacaine, and 0.5% ropivacaine, respectively. We compared their efficacy in terms of pulmonary and hemodynamic parameters, blockade quality, and complications.

**Results:** Of the total, 74 cases completed the study successfully. Sensory block attained the median dermatomal range of C2-T4/T5 in all the groups. Motor block was intense in ropivacaine group. Cardiorespiratory parameters decreased significantly in all the groups; however, none of the patients had any major complications except for bradycardia in 2 cases. Among the measured variables, the decrease in HR and PEF was more in lidocaine group while FVC and FEV1 declined to a greater extent in ropivacaine group. The lidocaine group required significantly more epidural top-ups compared to the other two groups.

**Conclusion:** We conclude that cervical epidural route can be safely used for thyroid surgery of patients without pre-existing cardiorespiratory disease, using either of local anaesthetics chosen for our study. Under the selected dose and concentrations, the decrease in cardiorespiratory parameters was lesser with bupivacaine.

**Note:** Trial was headed by the principal investigator in 2 different hospitals but not simultaneously. Initially the trial was started in BHU from Aug 2009 - Dec 2010 (55 cases) and then at Teerthankar Mahaveer Medical College (26 cases).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• euthyroid cases of ASA Physical Status I.
• III, height 145-165 cm, body mass index 25±10%, posted for thyroid surgeries.

Exclusion Criteria

deranged coagulation profile, H/o allergy to any local anaesthetic drugs, retrosternal goitre, cardiorespiratory disease, any contraindication to regional anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pulmonary [vital capacity (VC), peak expiratory force (PEF), and fraction of the vital capacity expired during the first second of a forced expiration (FEV1)] and hemodynamic parameters (Heart rate, Mean arterial pressure)	At baseline, 30 min post-CEA and end of the surgery.

Secondary Outcome Measures

Name	Time	Method
blockade quality, and complications	The block profile was evaluated at 5 min intervals for first 30 min after the induction of CEA and at 1hr intervals thereafter. Complication evaluated during perioperative period

Trial Locations

Locations (2)

Department of anaesthesia, Banaras Hindu university; 🇮🇳 Varanasi, UTTAR PRADESH, India

Department of anaesthesia, Teerthankar Mahaveer medical college; 🇮🇳 Moradabad, UTTAR PRADESH, India

Department of anaesthesia, Banaras Hindu university

🇮🇳Varanasi, UTTAR PRADESH, India

Gaurav Jain

Principal investigator

9936871711

gauravhld@gmail.com