Determining the effectiveness of different doses of celecoxib as a preventive measure in pain control after tibial fracture surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 450 patients. A table of random numbers was used for randomization.
Settings and conduct
After obtaining informed consent from the patients, all patients over 18 years of age who are candidates for orthopedic surgery of tibial fracture will be studied in the operating room of Imam Hossein hospital. People with uncontrolled underlying disease, patients treated with pain-relieving drugs, patients with neuropathy, history of allergic reactions to NSAIDs, suffering from mental illnesses, and any substance abuse will be excluded from the study. Patients will be assigned to one of the following groups by random block sampling method: celecoxib 100 mg group (group A), celecoxib 200 mg group (group B), celecoxib 400 mg group (group C), and placebo group (Group O). The intensity of pain is recorded using VAS (visual analog scale) and the incidence of nausea and vomiting in recovery and 6, 18, and 24 hours after surgery.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age are candidates for tibial bone fracture surgery who do not have significant underlying disease and neuropathy and are not being treated with pain-relieving drugs and do not abuse drugs.
Intervention groups
Patients in intervention groups receive different doses of celecoxib one hour before surgery. At the same time, the control group receives placebo capsules.
Main outcome variables
postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010800N9
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
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
2022-12-21, 1401/09/30
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Preoperative Celecoxib Administration on Pain Control After Tibial Fracture Surgery
Public title
Effect of celecoxib on pain control after orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Orthopedic surgery of tibial fracture with ORIF method
Exclusion criteria:
Uncontrolled underlying disease
Chronic use of pain-relieving drugs
Neuropathy
History of allergic reactions to NSAIDs
Mental illness
Substance abuse
Occurrence of medical problems after surgery
The need for care in the intensive care unit after surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
450
Randomization (investigator's opinion)
Randomized
Randomization description
At the time of admission in the operating room recovery, patients will be selected by 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 next stages of the non-interventional design will be equally divided into one of the following groups: celecoxib 100 mg group (A), celecoxib 200 mg group (B), celecoxib 400 mg group (C), and placebo group. (O).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 100 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 envelopes during the preparation of the envelopes of the groups. One hour before the operation and during recovery, group A patients will receive one celecoxib capsule and three placebo capsules, group B patients will receive two celecoxib capsules and two placebo capsules, group C patients will receive four celecoxib capsules, and group O patients will receive four placebo capsules. 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
Tehran - Shahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.413
Health conditions studied
1
Description of health condition studied
Comminuted fracture of shaft of tibia
ICD-10 code
S82.25
ICD-10 code description
Comminuted fracture of shaft of tibia
Primary outcomes
1
Description
postoperative pain
Timepoint
Recovery time, 6, 18, and 24 hours after surgery
Method of measurement
Using Visual Analogue Scale
Secondary outcomes
1
Description
Postoperative nausea and vomiting
Timepoint
Recovery time, 6, 18, and 24 hours after surgery
Method of measurement
Patient's statement
Intervention groups
1
Description
Intervention group: Group A patients receive one celecoxib capsule and three placebo capsules one hour before surgery.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Group B patients receive two celecoxib capsules and two placebo capsules.
Category
Treatment - Drugs
3
Description
Intervention group: Group C patients receive four celecoxib capsules.
Category
Treatment - Drugs
4
Description
Control group: Control group: Group O patients receive four placebo capsules.