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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epidural Catheter, Post Operative Pain

Intervention / Treatment
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* Procedure: tunneling epidural catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is an adult, between 18-80 years old with normal mentation. Patient has consented to general anesthesia and epidural catheter insertion for pain control after abdominal, thoracic and orthopedic surgery Patient is able to understand and provide informed consent to participate in the study. Exclusion Criteria: Patient is prone to coagulopathy. Patient has infection at injection site. Any Patient seen immediately before surgery-

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tunneling group<br>Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure. | Procedure: tunneling epidural catheter<br>* The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.<br>|
| Active Comparator: taping group<br>Epidural Catheter Insertion and fixation by use of adhesive tape without tunneling. | Procedure: tunneling epidural catheter<br>* The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard numerical pain score (NPS) | use numerical pain score from zero no pain and 10 worst immaginable pain | 5 days | 
| Rate of adverse events | infection, pain bleeding nerve damage, headache | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer patients, Epidural analgesia, Postoperative pain, tunneling