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Reporting
Study investigators clearly reported study objectives, eligibility criteria, and interventions of interest.
Participant characteristics clearly reported (e.g., study authors described the participants by age, BMI, gravidity, parity, and gestational age).
Study investigators reported no patients were lost to follow up.
External Validity
Not applicable.
Internal Validity
Study investigators reported that patients, anesthetist, surgeon, and other staff blinded to the contents of the medications.
The compliance with interventions is reliable across treatment arms.
The study investigators recruited participants from the same centre and over the same period.
The study investigators randomized participants to ensure random allocation.
Power
The study investigators recruited the required number of participants for each treatment arm based on the sample size calculations.
Conflict of Interest and Funding
The authors declared no conflicts of interests.
The authors did not receive financial support or funding.
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Reporting
The report does not clearly describe the outcome relevant to this report, total morphine consumption, specifically the length of follow-up time.
Adverse events not reported.
For results relevant to our report, study investigators reported the P values < 0.05 when there was a statistically significant difference between the 2 arms of interest; thus, actual P values not reported.
Potential confounders not reported. For example, study investigators did not compare the distribution of other potential confounding factors, such as previous Caesarean deliveries and baseline pain.
External Validity
Unable to determine if the individuals asked to participate in the study were representative of the entire population from which they are recruited.
The study investigators conducted the trial from a single centre in Turkey. It is unclear if the setting is representative of that in the population.
Internal Validity
Unable to determine whether patients had different lengths of follow up for the outcome cumulative opioid use; therefore, it is unclear if analyses were needed to adjust for different lengths of follow up.
Unclear if the main outcome measures were accurate.
Power
Not applicable
Conflict of Interest and Funding
Not applicable
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Reporting
The study investigators clearly described their study hypotheses, main outcomes, eligibility criteria, and intervention of interest.
Potential confounders reported (i.e., study investigators described treatment groups by age, sex, BMI, race, ethnicity, baseline pain at rest and ambulation, and surgical time).
Study investigators clearly reported results (i.e., included simple outcome data, effect estimates, estimates of random variability, confidence intervals, and P values for the main outcomes).
Adverse events disclosed: study investigators reported no adverse events related to treatment.
External Validity
Not applicable
Internal Validity
No data dredging (i.e., unreported/posthoc analyses) apparent.
All participants recruited from the same population and over the same period.
Study investigators used appropriate statistical tests to analyze results.
The compliance with interventions is reliable across treatment arms.
The study investigators followed all participants for the same amount of time across main outcomes.
The study investigators randomized participants to ensure random allocation.
The study investigators reported that patients, pharmacists, physicians, and research staff blinded adequately throughout the study.
The results of the Bang’s blinding index indicated that intervention assignment was adequately concealed from participants.
Power
The study investigators recruited the required number of participants per treatment arm based on sample size calculations.
Conflict of Interest and Funding
Not applicable
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Reporting
The study investigators did not describe the characteristics of participants lost to follow up.
The study investigators did not adequately describe their numerical rating scale to measure baseline pain at rest and ambulation.
External Validity
The study was conducted at a high-volume orthopedic hospital with specialized surgeons and anesthesiologists and an experienced acute pain service. It is unclear if the setting or the treatment is representative of that in the population.
Unable to determine if the individuals asked to participate in the study were representative of the entire population from which they are recruited. The PRISMA flow diagram shows that a proportion of individuals screened were excluded based on a physician’s judgement (i.e., “Not appropriate as per MD”).
Internal Validity
The study investigators noted differences in race and surgical time between treatment groups but did not address its impact.
Power
Not applicable
Conflict of Interest and Funding
One or more study investigators declared a conflict of interest, such as financial payment, indirect or direct institutional support, or association with a biomedical entity.
A private pharmaceutical company funded the study, which was the same company as the intervention drug used.
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