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NCT Number: NCT03706352

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

tunneling epidural catheter

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

King Hussein Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2018
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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