Health Condition 1: E041- Nontoxic single thyroid nodule
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. ASA Physical Status I and II 2. Patients undergoing elective ipsilateral axillo-breast approach(IABA) or bilateral axillo-breast approach (BABA) of endoscopic thyroid surgery.
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to give consent for the study. 2. Known hypersensitivity to local anaesthetic. 3. Radical or extensive lymph node neck dissection. 4. History or confirmed diagnosis of bleeding diathesis or coagulopathies. 5. Infection at block sites. 6. Large thyroid masses not amenable to endoscopic thyroidectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the postoperative pain at rest at 6 hours postoperatively using a 0-100 mm visual analogue scale (VAS) in the conventional practice group (GA + LA infiltration) and the intervention group [ipsilateral pecto-intercostal fascial block (PICFB) and intermediate cervical plexus block (IMCPB) as adjuncts to GA + LA infiltration].Timepoint: At 6 hours postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between the two groups of: The total intra-operative fentanyl requirement Timepoint: from beginning to end of surgery.;VAS at rest Timepoint: at 0, 1, 2, 4, 12, 18 & 24 hours postoperatively;VAS on movement (ipsilateral arm abduction up to 90°, swallowing of saliva). Timepoint: at 0, 1, 2, 4, 6, 12, 18 & 24 hours postoperatively.;The VAS specifically over ipsilateral anterior chest, axilla & neck will also be assessed at rest at the above time pointsTimepoint: at 0, 1, 2, 4, 6, 12, 18 & 24 hours postoperatively;The VAS specifically on the ipsilateral anterior chest, axilla & neck areas will also be assessed on movement at the above time points.Timepoint: at 0, 1, 2, 4, 6, 12, 18 & 24 hours postoperatively.;The cumulative VAS over 24 hours at rest & movementTimepoint: 0-24 hours;Time to demand of first rescue analgesic Timepoint: From end of surgery to first analgesic demand (VAS equal to or more than 40 after the end of surgery);The total peri-operative 24-hour analgesic requirementTimepoint: 0-24 hours.;Incidence of post-operative nausea & vomiting (PONV)Timepoint: 0-24 hours.;Adverse events if any observed such as hoarseness of voice, Horner’s syndrome & difficulty in swallowing or any features of local anaesthetic toxicity.Timepoint: 0-24 hours.;Assessment of the sensory dermatomes anaesthetized to cold & pin prick 20 minutes post block & pre-induction in the intervention group.Timepoint: 20 minutes post block. | — |
Countries
India
Contacts
All India institute of Medical Sciences, New Delhi