Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-29 @ 11:19 AM
Study NCT ID:
NCT03806335
Status:
SUSPENDED
Last Update Posted:
2022-01-18
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy
Sponsor:
Makassed General Hospital
Organization:
Study Overview
Official Title:
The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial
Status:
SUSPENDED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: