Epidural CatheterNCT03706352
Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial
A study testing tunneling epidural catheter in people with Epidural Catheter and Post Operative Pain, run by King Hussein Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidural Catheter, Post Operative Pain
- What is being tested?
- tunneling epidural catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2015to 13 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient is prone to coagulopathy.
- Patient has infection at injection site.
- Any Patient seen immediately before surgery-
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidural Catheter, Post Operative Pain
- Being tested
- tunneling epidural catheter
- Keywords
- Cancer patients, Epidural analgesia, Postoperative pain, tunneling
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneling epidural catheterProcedure or surgery
The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.
| Study group | Role | What they receive |
|---|---|---|
| tunneling group | Experimental | Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure. Receives: Procedure: tunneling epidural catheter |
| taping group | Active comparator | Epidural Catheter Insertion and fixation by use of adhesive tape without tunneling. Receives: Procedure: tunneling epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (2)
standard numerical pain score (NPS)
use numerical pain score from zero no pain and 10 worst immaginable pain
Measured: 5 days
Rate of adverse events
infection, pain bleeding nerve damage, headache
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start14 Apr 2015
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Abu Khudair, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706352
- Sponsor's protocol ID
- 13KHCC64
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain: Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial
- ClinicalTrials.gov ID
- NCT03706352
- Acronym / sponsor ID
- 13KHCC64
- Conditions
- Epidural Catheter, Post Operative Pain
- Keywords
- Cancer patients, Epidural analgesia, Postoperative pain, tunneling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tunneling group | Experimental | Procedure: tunneling epidural catheterEpidural Catheter Insertion and fixation by subcutaneous tunneling procedure. |
| taping group | Active comparator | Procedure: tunneling epidural catheterEpidural Catheter Insertion and fixation by use of adhesive tape without tunneling. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is an adult, between 18-80 years old with normal mentation.
Key exclusion criteria (3 listed)
- Patient is prone to coagulopathy.
- Patient has infection at injection site.
- Any Patient seen immediately before surgery-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tunneling epidural catheterThe epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point. | Procedure or surgery | taping group, tunneling group |
Primary outcome
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.
2 secondary outcomes
standard numerical pain score (NPS)
Time frame: 5 days
Rate of adverse events
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Epidural Catheter
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
Epidural; Anesthesia, Catheter Complications
RecruitingObservational study
Failing Epidural Analgesia During Labor
Failed Epidural Analgesia, Post-partum Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tunneling epidural catheter in people with Epidural Catheter and Post Operative Pain, run by King Hussein Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Rate of dislodgment between the two groups (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.