Determining the effect of prophylactic administration of celecoxib on pain after ankle fracture surgery
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 55 patients. A table of random numbers will be used for randomization.
Settings and conduct
After obtaining informed consent, patients over 18 years of age who are candidates for ankle fracture orthopedic surgery will be studied in the operating room of Imam Hossein (AS) Hospital. People with uncontrolled underlying diseases, treated with drugs that affect pain, suffering from neuropathy, history of allergic reactions to NSAIDs, suffering from mental diseases, and any third use of drugs will be excluded from the study. Patients will be placed in one of the following groups by random block sampling method: 600 group, 400 group, and placebo group. Pain intensity was recorded using VAS (visual analog scale) and the incidence of nausea and vomiting during recovery and 6, 24, and 72 hours after surgery.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include all patients over 18 years of age who are candidates for tibial bone fracture surgery. The conditions for not entering the study include people without significant underlying disease and neuropathy, and people who do not use pain-relieving drugs and do not abuse drugs.
Intervention groups
Patients in intervention groups receive different doses of celecoxib the night before surgery and one hour before surgery. The control group receives placebo capsules at the same time.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010800N11
Registration date:2023-05-06, 1402/02/16
Registration timing:prospective
Last update:2023-05-06, 1402/02/16
Update count:0
Registration date
2023-05-06, 1402/02/16
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the preventive effect of celecoxib on pain after ankle fracture surgery
Public title
Effect of celecoxib on pain after orthopedic surgery
At the time of admission to the orthopedic department, the patients will be randomized using the permutation block method using random numbers obtained from the table of random numbers written on the card, which will be placed in sealed non-transparent envelopes, by an anesthesia technician who is in the stages. Next, there will be no interference plan, they will be placed equally in one of the following groups. Patients in the control group will receive two placebo capsules the night before surgery and one placebo capsule one hour before surgery. Group 400 patients will receive two celecoxib 200 mg capsules the night before surgery and one placebo capsule one hour before surgery. Group 600 patients will receive two 200 mg celecoxib capsules the night before the operation and another 200 mg celecoxib capsule one hour before the operation.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 200 mg celecoxib capsules and placebo capsules will be used, in which the celecoxib content of the capsule is replaced with an approved artificial sweetener powder. These capsules will be placed inside the envelope during the preparation of the groups' envelopes and will be given to the patient by the ward nurse (the night before the operation) and the anesthesia technician (when entering the operating room), who will not be aware of the patient's next condition. The next follow-up of the patients and data recording will be done by the anesthesiologist who is not aware of the patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Next to Ayatollah Taleghani Hospital, Yemen Street, Shahid Arabi Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.077
Health conditions studied
1
Description of health condition studied
Bimalleolar fracture of lower leg
ICD-10 code
S82.84
ICD-10 code description
Bimalleolar fracture of lower leg
Primary outcomes
1
Description
Postoperative pain
Timepoint
6, 24 and 72 hours after the operation
Method of measurement
Using Visual Analogue Scale
Secondary outcomes
1
Description
Postoperative nausea and vomiting
Timepoint
6, 24, and 72 hours after surgery
Method of measurement
Patient's statement
Intervention groups
1
Description
Intervention group: Patients in the 400 group will receive two celecoxib 200 mg capsules the night before surgery and one placebo capsule one hour before surgery.
Category
Treatment - Drugs
2
Description
Intervention group: Group 600 patients will receive two 200 mg celecoxib capsules the night before the operation and another 200 mg celecoxib capsule one hour before the operation.
Category
Treatment - Drugs
3
Description
Control group: Patients in the placebo group will receive two placebo capsules the night before the operation and another placebo capsule one hour before the operation.