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The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03806335
Recruitment Status : Suspended (Lack of patients)
First Posted : January 16, 2019
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, 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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Other: Infiltration Other: Placebo Other: General anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Infiltration
Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
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: General anesthesia
All patients will receive general anesthesia prior to infiltration

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




Primary Outcome Measures :
  1. Post operative pain [ Time Frame: 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 :
  1. PONV [ Time Frame: within 10 days after the operation ]
    Post operative nausea and vomiting (PONV) will be assessed through a questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806335


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja Makassed General Hospital
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Responsible Party: Zoher Naja, Anesthesiologist, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03806335    
Other Study ID Numbers: 32015
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs