The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Infiltration

Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.

Group Type EXPERIMENTAL

Infiltration

Intervention Type OTHER

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%

General anesthesia

Intervention Type OTHER

All patients will receive general anesthesia prior to infiltration

Placebo

Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive 2.5 ml normal saline in each tonsil

General anesthesia

Intervention Type OTHER

All patients will receive general anesthesia prior to infiltration

Interventions

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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%

Intervention Type OTHER

Placebo

Patients will receive 2.5 ml normal saline in each tonsil

Intervention Type OTHER

General anesthesia

All patients will receive general anesthesia prior to infiltration

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No