Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

Peritonsillar Infiltration With Levobupivacaine for Relief of Posttonsillectomy Pain: Does Concentration Have Any Effect?

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Group S; Drug: Group LL; Drug: Group HL

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group S; Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline	Other: Group S; Peritonsillar infiltration with saline 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.; Other Names: Saline
Active Comparator: Group LL; Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil).	Drug: Group LL; Peritonsillar infiltration with low-dose of levobupivacaine 0.25%. 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.; Other Names: Chirocaine 0.25%
Active Comparator: Group HL; Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil).	Drug: Group HL; Peritonsillar infiltration with high dose of levobupivacaine 0.5%. 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.; Other Names: Chirocaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postoperative pain	pain assessed with FPRS (Faces pain rating scale)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of dysphagia	number of participants with dysphagia and without dysphagia.	24 hours

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: K.Sanem Cakar Turhan, Specialist, Ankara University

Publications and helpful links

General Publications

• Cakar Turhan KS, Salviz EA, Beton S, Timuroglu ST, Catav S, Ozatamer O. Peritonsillar infiltration with levobupivacaine for posttonsillectomy pain relief: does concentration have any effect? A double-blind randomized controlled clinical study. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1276-84.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 22, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: levobupivacaine; posttonsillectomy pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: 134-3866