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

Postoperative Pain: 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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Epidural Catheter
• Intervention / Treatment: Procedure: tunneling epidural catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Hussein Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2015
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cancer patients, Epidural analgesia, Postoperative pain, tunneling
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 13KHCC64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No