Clinical Trials Logo

Clinical Trial Summary

In elective gynecology and general surgery patients age 18 and over requiring endotracheal tube (ETT) intubation, what is the efficacy of ropivacaine 0.5% vs. lidocaine 2% as the medium to inflate the ETT cuff, compared to the standard of air, in reducing the incidence and severity of POST on post-op day one?


Clinical Trial Description

We plan a randomized clinical trial comparing postoperative sore throat between three groups: 1) ETT cuff inflated with ropivacaine, 2) ETT cuff inflated with lidocaine, and 3) ETT cuff inflated with air (standard care).

The Saskatoon Health Region has on average 24 elective operating rooms in use every weekday, with tracheal intubation being a common intervention in patients coming for surgery. To aid with homogeneity, only ASA 1-3 gynecology and general surgery patients who require endotracheal intubation with major surgery criteria will be recruited. The criteria for major surgery will be defined as those that require hospitalization for more than one day.(1) Patients under the age of 18 and those with pre-operative sore throat will be excluded. In the pre-operative holding area, the anesthesia provider will explain the risk of anesthesia. Oral and written consent will be obtained after the anesthesia provider (staff or resident) has explained the risk and benefits of the research project. After informed consent has been received the patients will be randomized to one of the two intervention groups or to the control using computer-generalized random sequence. The anesthetic provided will be chosen based on clinical grounds as per the anesthesiologist's discretion. The following will be documented by the anesthesiologist: if an oral airway was used at any time, size of endotracheal tube, number of intubation attempts, the Cormack-Lehane intubation grade, the number of intubation attempts required to be successful, and if a stylet was required to secure the ETT. The ETT cuff will be inflated with either lidocaine 2%, ropivacaine 0.5%, or air. To inflate the cuff, the stethoscope guided inflation technique will be used.(2) For all groups, the anesthetist will document the volume in milliliters instilled into the cuff. Nitrous oxide will not be used at any time during the anesthetic, as nitrous oxide is associated with an increase of the ETT cuff pressure and thus potential for mucosal damage.(3) The anesthesia provider will not be blinded to the interventions. All patients will be anesthetized when the medium is placed in the ETT, thus patients will be blinded. Gentle suctioning of the oropharynx may be administered at the end of the surgery.

Documentation will be made if patients are smokers or have hyperactive airway disease (ex. asthma, COPD, or URTI in the last 4 weeks). In addition, age, sex, ASA status, duration of intubation and type of surgery will be documented. The anesthesia provider will make note of the incidence of coughing prior to extubation as mild (<5 coughs), moderate (5-10 coughs), or severe (>10 coughs); with cough defined as the sudden expelling of air from the lungs with a loud noise. Prior to discharge from the post anesthetic care unit (PACU), the resident researcher who is blinded to patient allocation will assess for the presence of sore throat (defined as pain in the throat) with a "yes" or "no" evaluation. If patients report yes, then they will be report the severity using the Numerical Rating Scale (NRS) of 0-10.(4) Surgical site pain will be assessed using the NRS of 0-10. The following will also be noted in PACU: the presence of dysphagia (defined as difficulty in swallowing), and hoarseness or dysphonia (defined as a rough or harsh voice pattern) by a "yes" or "no" evaluation. The time spent in PACU will also be recorded.

The resident researcher will perform bed side evaluation of all participants on post-op day one for the presence of sore throat with a "yes" or "no" evaluation. If patients indicate "yes", then the severity will be reported using the NRS. To ensure surgical pain is not distracting patients, the research will also assess surgical pain using the NRS. The presence of dysphagia and hoarseness or dysphonia will be assessed by a "yes" or "no" evaluation. Finally, patient satisfaction with their anesthesia will be assessed on post-operative day 1 with a 5-point Likert scale with the following categories: very satisfied, satisfied, neither, dissatisfied, or very dissatisfied. If a patient is discharged home on post-op day one prior to the resident researcher performing the bed side evaluation, the patient will be contacted by phone using the phone number proved at the time of hospital registration.

The sample size for the study is based on studies included in the meta-analysis by Lam et al. (5) The sample size required to provide a 80% power for a 0.05 significance level between the three groups is 14 per group, but 20 per group will be recruitment to account for patient drop-out.

The data will be collected by the resident researcher. Statistical analysis will be completed by a statistician within the anesthesia department. The outcomes of POST, surgery pain, dysphagia and hoarseness in the PACU and POD1, as well as the outcomes cough and cuff-pressure, will be analyzed using Pearson chi-square. Fisher's Exact test will be used where cell count of a variable is less than five. Effect size for the categorical primary and secondary outcomes will be calculated using Cramer's V and the effect size for the continuous secondary outcomes will be calculated using Eta squared (ƞ2) for Kruskal Wallis-H. If continuous variable score do not follow normal distributions we will compare the continuous variables for treatment groups (air, ropivacaine and lidocaine) using the Kruskal-Wallis test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03563963
Study type Interventional
Source University of Saskatchewan
Contact
Status Completed
Phase N/A
Start date August 1, 2018
Completion date September 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT01453400 - Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain Phase 3
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Recruiting NCT01681667 - Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain Phase 4
Completed NCT00527852 - Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis N/A
Completed NCT02178293 - Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride Phase 4
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Withdrawn NCT02535962 - Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) Phase 2
Not yet recruiting NCT02252419 - Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat N/A
Completed NCT00798018 - Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena N/A
Completed NCT00535093 - An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel N/A
Completed NCT00148499 - Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Recruiting NCT03720301 - The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat N/A
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Completed NCT01048866 - A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis Phase 3
Completed NCT01049334 - A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis Phase 3
Completed NCT01398696 - Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour Phase 4
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3