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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706352
• Other study ID #: 13KHCC64
• Status: Completed
• Phase: N/A
• Start date: April 14, 2015
• Est. completion date: July 13, 2017

Study information

• Verified date: October 2018
• Source: King Hussein Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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-

Related Conditions & MeSH terms

• Epidural Catheter
• Pain, Postoperative
• Post Operative Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Hussein Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	standard numerical pain score (NPS)	use numerical pain score from zero no pain and 10 worst immaginable pain	5 days
Secondary	Rate of adverse events	infection, pain bleeding nerve damage, headache	5 days