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

King Hussein Cancer Center

Status: Completed

Conditions: Epidural Catheter; Post Operative Pain

Treatments: Procedure: tunneling epidural catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03706352

13KHCC64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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-

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

tunneling group

Experimental group

Description:

Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure.

Treatment:

Procedure: tunneling epidural catheter

taping group

Active Comparator group

Description:

Epidural Catheter Insertion and fixation by use of adhesive tape without tunneling.

Treatment:

Procedure: tunneling epidural catheter