An interventional study of tunneling epidural catheter in Epidural Catheter and Post Operative Pain, sponsored by King Hussein Cancer Center. Completed. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by King Hussein Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 200 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →King Hussein Cancer Center is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient is an adult, between 18-80 years old with normal mentation.
Exclusion Criteria:
Patient is prone to coagulopathy.
Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure.
Procedure: tunneling epidural catheter
Epidural Catheter Insertion and fixation by use of adhesive tape without tunneling.
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.
Difference in Rate of dislodgment between the two groups
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.
Time frame: 5 days
standard numerical pain score (NPS)
use numerical pain score from zero no pain and 10 worst immaginable pain
Time frame: 5 days
Rate of adverse events
infection, pain bleeding nerve damage, headache
Time frame: 5 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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King Hussein Cancer Center