Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

NCT02322346 | Completed Phase 4

• 1 other identifier: 134-3866
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pain

Keywords

posttonsillectomy pain; levobupivacaine

Outcome Measures

Primary Outcomes (1)

• Change in postoperative pain

  pain assessed with FPRS (Faces pain rating scale)

  24 hours

Secondary Outcomes (1)

• Presence of dysphagia

  24 hours

Study Arms (3)

Group S

PLACEBO COMPARATOR

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

Other: Group S

Group LL

ACTIVE COMPARATOR

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

Drug: Group LL

Group HL

ACTIVE COMPARATOR

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

Drug: Group HL

Interventions

Group S OTHER

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.

Also known as: Saline

Group S

Group LL DRUG

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.

Also known as: Chirocaine 0.25%

Group LL

Group HL DRUG

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.

Also known as: Chirocaine 0.5%

Group HL

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Related Publications (1)

• 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.

  PMID: 25912590 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• K.Sanem Cakar Turhan, Specialist

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 23, 2014
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 23, 2014

Record last verified: 2014-12