NCT03706352

Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial

Postoperative Pain: Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: King Hussein Cancer Center · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a prospective randomized single blinded study in patients planned to undergo general anesthesia and epidural catheter insertion for pain control after abdominal, thoracic and orthopedic surgery. Patients meeting participation criteria will be selected and enrolled sequentially. The study recruitment will be carried out over one year with follow-up for each patient until either the catheter is dislodged or once decided that the patient is to be discontinued from the epidural pain control.

Detailed description

Study Population and Sample Size The study aims to enroll 200 adult patients planned to undergo general anesthesia and epidural catheter insertion. The study sample will be selected to fulfill the selection criteria. Patients will be selected if they meet the following participation criteria: Planned Procedures and Assessments Follow -up on dislodgments, adverse events, pain and pain relief assessment, standard practice Study Site All study conduction from start to end including procedures and assessments, data acquisition and analysis and final study conclusion report and any publications will be at King Hussein Cancer Center (KHCC). Ethical Considerations The study will be submitted to the KHCC IRB for review. The study will not start before IRB approval is obtained. All patients who provide consent to participation in the study will be randomized and enrolled. Statistical Plan Descriptive statistics will be used to present the two groups baseline characteristics. Comparison between groups will be carried out using Chi-square test or t-test or Wilcox on rank test as appropriate. Comparison between groups while adjusting for other variables will be carried out using logistic regression. Odds ratios along with their 95% confidence intervals will be calculated.

Conditions

• Epidural Catheter
• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	tunneling epidural catheter	The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.

Timeline

• Start date: 2015-04-14
• Primary completion: 2017-07-13
• Completion: 2017-07-13
• First posted: 2018-10-16
• Last updated: 2018-10-16