Can local anaesthesia in the throat after removal of throat tonsils reduce pain

Can topical anaesthesia with bupivacaine reduce pain after tonsillectomy?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002862-15-NO

Enrollment

Registered

2020-09-04

Start date

2021-03-03

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local pain after tonsillectomy, both at rest and during swallowing. Assessed by self-reporting at 1, 2, 3, 4, 5, 6 hours and 1,2,4 and 6 days after surgery.

Interventions

Trade Name: Marcain Product Name: bupivacaine Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Oropharynge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients undergoing isolated tonsillectomy from the age of 5 years and older. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Patients using opioids regularly.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to investigate whether patients who get bupivacaine on the gauze swab used for hemostasis after tonsillectomy has less pain the first hours and days postoperatively compared to patients that have physiological saline solution (placebo). ;Secondary Objective: Another objective is to measure blood concentration of bupivacaine after this topical administration of bupivacaine.;Primary end point(s): Self-reported pain at rest and during swallowing indicated by the numerical rating scale for patients aged 10 years and older, and indicated by the faces pain scale-revised for patients aged 5-10 years old.;Timepoint(s) of evaluation of this end point: Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively.	—

Measure

Time frame

Main Objective: The main objective of the trial is to investigate whether patients who get bupivacaine on the gauze swab used for hemostasis after tonsillectomy has less pain the first hours and days postoperatively compared to patients that have physiological saline solution (placebo). ;Secondary Objective: Another objective is to measure blood concentration of bupivacaine after this topical administration of bupivacaine.;Primary end point(s): Self-reported pain at rest and during swallowing indicated by the numerical rating scale for patients aged 10 years and older, and indicated by the faces pain scale-revised for patients aged 5-10 years old.;Timepoint(s) of evaluation of this end point: Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Need for additional pain-killers, nausea, vomiting, reduced apetite. 2. Blood concentration of bupivacaine;Timepoint(s) of evaluation of this end point: 1. 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively. 2. Pilot study including 2 patients, with frequent blood sampling (every 15 minutes until 90 minutes) to find the three optimal time-points for blood sampling in the whole cohort.	—

Measure

Time frame

Secondary end point(s): 1. Need for additional pain-killers, nausea, vomiting, reduced apetite. 2. Blood concentration of bupivacaine;Timepoint(s) of evaluation of this end point: 1. 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively. 2. Pilot study including 2 patients, with frequent blood sampling (every 15 minutes until 90 minutes) to find the three optimal time-points for blood sampling in the whole cohort.

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Countries

Norway

Contacts

Public ContactErik waage nielsen

Nordland Hospital. Bodø

erik.waage.nielsen@gmail.com+4790788035

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026