Effects of Neuraxial Blockade May Be Difficult To Study Using Large Randomized Controlled Trials: The PeriOperative Epidural Trial (POET) Pilot Study
2009

Feasibility of Studying Neuraxial Blockade in Surgery

Sample size: 112 publication 10 minutes Evidence: low

Author Information

Author(s): Peter T. Choi, W. Scott Beattie, Gregory L. Bryson, James E. Paul, Homer Yang

Primary Institution: University of British Columbia

Hypothesis

Can a large multicentre randomized controlled trial effectively study the effects of neuraxial blockade on perioperative outcomes?

Conclusion

The study found that only the follow-up target was met, indicating that a large multicentre trial may not be feasible for studying neuraxial blockade.

Supporting Evidence

  • Only 22.7% of eligible patients consented to participate in the study.
  • Recruitment rate was 0.5±0.3 subjects per week per centre.
  • 97.0% of randomized subjects were successfully followed for the entire study period.

Takeaway

This study tried to see if a big research project could be done to check if a certain type of pain relief during surgery is helpful, but it turned out to be too hard to get enough people to join.

Methodology

Patients aged 45 and older undergoing non-cardiothoracic surgery were randomly assigned to receive either neuraxial anesthesia or intravenous opioid analgesia, with outcomes assessed for recruitment rates and follow-up.

Potential Biases

Potential bias due to clinician preferences affecting patient recruitment and allocation.

Limitations

The recruitment rate was lower than expected, and many eligible patients declined to participate.

Participant Demographics

{"mean_age":70.6,"sex_distribution":{"female":27,"male":74},"comorbid_conditions":{"coronary_artery_disease":26,"peripheral_vascular_disease":24,"hypertension":65,"diabetes":25}}

Statistical Information

Confidence Interval

95% CI 8.5%–29.0%

Digital Object Identifier (DOI)

10.1371/journal.pone.0004644

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