The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

NCT03806335 | Suspended

• 1 other identifier: 32015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  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.

  within 10 days after the operation

Secondary Outcomes (1)

• PONV

  within 10 days after the operation

Study Arms (2)

Infiltration

EXPERIMENTAL

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

Other: Infiltration; Other: General anesthesia

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Other: General anesthesia

Interventions

Infiltration 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%

Infiltration

Placebo OTHER

Patients will receive 2.5 ml normal saline in each tonsil

Placebo

General anesthesia OTHER

All patients will receive general anesthesia prior to infiltration

Infiltration; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with total or partial tonsillectomy with or without adenoidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Zoher Naja

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: January 7, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)