Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Group HL; Other: Group S; Drug: Group LL

• Registration Number: NCT02322346
• Lead Sponsor: Ankara University

Brief Summary

The investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding

Detailed Description

72 ASA I-II patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. The indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms.

The patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline.

The mean arterial pressure (MAP) and heart rates (HR) of all patients were recorded during the whole anesthesia and surgical procedures. The duration of anesthesia and surgery were also recorded. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.

During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-12
• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2014-12-22
• Last Update Submitted: 2014-12-22
• Study First Posted: 2014-12-23
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms
• Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms.

Exclusion Criteria

• Hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine
• Presence of coagulation disorders and chronic diseases
• Presence of regular use of analgesics
• Presence of analgesic use within 24 hours prior to surgery
• Presence of upper respiratory system infection
• Inability to understand the pain scales, being unable to communicate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group HL	Group HL	Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil).
Group S	Group S	Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline
Group LL	Group LL	Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil).

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain	24 hours	pain assessed with FPRS (Faces pain rating scale)

Secondary Outcome Measures

Name	Time	Method
Presence of dysphagia	24 hours	number of participants with dysphagia and without dysphagia.