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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706352
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hussein Abu Khudair, King Hussein Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Epidural Catheter Post Operative Pain Procedure: tunneling epidural catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Pain: Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial
Actual Study Start Date : April 14, 2015
Actual Primary Completion Date : July 13, 2017
Actual Study Completion Date : July 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tunneling group
Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure.
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.

Active Comparator: taping group
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.




Primary Outcome Measures :
  1. Difference in Rate of dislodgment between the two groups [ Time Frame: 5 days ]
    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.


Secondary Outcome Measures :
  1. standard numerical pain score (NPS) [ Time Frame: 5 days ]
    use numerical pain score from zero no pain and 10 worst immaginable pain

  2. Rate of adverse events [ Time Frame: 5 days ]
    infection, pain bleeding nerve damage, headache



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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-
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Responsible Party: Hussein Abu Khudair, chairman department of anesthesiology and pain management, King Hussein Cancer Center
ClinicalTrials.gov Identifier: NCT03706352    
Other Study ID Numbers: 13KHCC64
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hussein Abu Khudair, King Hussein Cancer Center:
Cancer patients, Epidural analgesia, Postoperative pain, tunneling
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations