Clinical trial NCT02322346: Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain
Official title: Peritonsillar Infiltration With Levobupivacaine for Relief of Posttonsillectomy Pain: Does Concentration Have Any Effect?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: posttonsillectomy pain
levobupivacaine
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Presence of dysphagia
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: K.Sanem Cakar Turhan, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.