NCT04825704

Bupivacaine in Tonsillectomy

Can Topical Administration of Bupivacaine Reduce Pain After Tonsillectomy?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Nordlandssykehuset HF · Academic / Other
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

A placebo-controlled and double-blind study is planned according to current legislation and ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after tonsillectomy, and 50% receive 0.9% sodium chloride. Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding, fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2, 3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with "mixed models" statistics and the results will be published in a peer-based journal.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Bupivacaine	Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
DRUG	Sodium chloride	Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.

Timeline

• Start date: 2021-10-27
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2021-04-01
• Last updated: 2023-08-04

Locations

1 site across 1 country: Norway