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

NCT03706352 | Completed

• 1 other identifier: 13KHCC64
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epidural Catheter; Post Operative Pain

Keywords

Cancer patients, Epidural analgesia, Postoperative pain, tunneling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• standard numerical pain score (NPS)

  5 days

• Rate of adverse events

  5 days

Study Arms (2)

tunneling group

EXPERIMENTAL

Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure.

Procedure: tunneling epidural catheter

taping group

ACTIVE COMPARATOR

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

Procedure: tunneling epidural catheter

Interventions

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.

taping group; tunneling group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient is prone to coagulopathy.
• Patient has infection at injection site.
• Any Patient seen immediately before surgery-

Sponsors & Collaborators

• King Hussein Cancer Center: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chairman department of anesthesiology and pain management

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: April 14, 2015
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share