The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Not Applicable

Suspended

• Conditions: Post Operative Pain
• Interventions: Other: Infiltration; Other: Placebo; Other: General anesthesia

• Registration Number: NCT03806335
• Lead Sponsor: Makassed General Hospital

Brief Summary

Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

Detailed Description

The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria

• patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
• patients who have diabetes
• patients who have bleeding problems
• patients who are suspected to have signs of acute pharyngeal infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infiltration	Infiltration	Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
Placebo	Placebo	Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
Infiltration	General anesthesia	Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
Placebo	General anesthesia	Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.

Primary Outcome Measures

Name	Time	Method
Post operative pain	within 10 days after the operation	Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.

Secondary Outcome Measures

Name	Time	Method
PONV	within 10 days after the operation	Post operative nausea and vomiting (PONV) will be assessed through a questionnaire

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon