Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

Ankara University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Group LL; Other: Group S; Drug: Group HL

Study type: Interventional

Funder types: Other

Identifiers

NCT02322346

134-3866

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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70 participants in 3 patient groups, including a placebo group

Group S

Placebo Comparator group

Description:

Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline

Treatment:

Other: Group S

Group LL

Active Comparator group

Description:

Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil).

Treatment:

Drug: Group LL

Group HL

Active Comparator group

Description:

Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil).

Treatment:

Drug: Group HL