Post Operative Pain
Conditions
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.
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.
Interventions
OTHERInfiltration
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%
OTHERPlacebo
Patients will receive 2.5 ml normal saline in each tonsil
OTHERGeneral anesthesia
All patients will receive general anesthesia prior to infiltration
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| PONV | within 10 days after the operation | Post operative nausea and vomiting (PONV) will be assessed through a questionnaire |
Countries
Lebanon
Outcome results
None listed