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

• ClinicalTrials.gov Identifier: NCT03706352
• Recruitment Status: Completed
• First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: King Hussein Cancer Center
• Information provided by (Responsible Party): Hussein Abu Khudair, King Hussein Cancer Center

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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-

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• Last Update Posted: October 16, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations