NCT03806335

The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
OTHER	Infiltration	The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%
OTHER	Placebo	Patients will receive 2.5 ml normal saline in each tonsil
OTHER	General anesthesia	All patients will receive general anesthesia prior to infiltration

Timeline

• Start date: 2019-01-07
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2019-01-16
• Last updated: 2022-01-18

Locations

1 site across 1 country: Lebanon