Epidural Catheter Fixation Techniques for Thoracic Epidural Management

Overseen By Ami Stuart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Pregnancy, Allergy to adhesives, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods for securing an epidural catheter during thoracic (upper back) procedures. It compares three techniques: Dermabond (a skin adhesive), Mastisol (a medical adhesive spray), and Grip-Lok (a fixation bandage). The goal is to determine which method best keeps the catheter in place. Individuals undergoing surgery with a thoracic epidural may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to advancements in medical procedures and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these thoracic epidural catheter fixation techniques are safe?

Research has shown that thoracic epidural anesthesia is generally safe, with a low risk of complications when performed correctly. One study found that Dermabond, a type of skin glue, might better secure epidural catheters. This suggests it could be a reliable option without causing major side effects.

For the Grip-Lok bandage, studies have not identified any major safety issues, but careful application remains essential. The success rate for this method is high, with only a small chance of failure.

Both Dermabond and Grip-Lok secure epidural catheters, a common practice in pain management. Serious complications are rare when the procedure is performed precisely, reducing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these fixation techniques for thoracic epidural catheters because they aim to improve how securely and effectively these catheters are held in place. The study is exploring three different methods: Dermabond, Mastisol, and Grip-Lok, each offering unique advantages. Dermabond provides a strong bond by sealing the insertion site with a skin adhesive, while Mastisol enhances adhesion around the site with a special spray. Grip-Lok offers a different approach by using a fixation bandage that secures the catheter through a mechanical grip. By comparing these methods, researchers hope to discover which technique offers the best stability and comfort for patients, potentially enhancing the overall effectiveness of pain management during thoracic procedures.

What evidence suggests that these thoracic epidural catheter fixation techniques could be effective?

This trial studies different techniques for thoracic epidural catheter fixation. Research has shown that Dermabond, a type of skin glue used in one trial arm, effectively keeps epidural tubes in place by adhering to the skin at the insertion site, reducing the risk of slippage. Another trial arm uses Grip-Lok, which studies have shown can securely hold tubes with a special bandage that grips the tube tightly, maintaining its position. Both methods aim to keep the tube steady to ensure proper pain relief during procedures. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for surgical patients aged 18 or older who are scheduled to receive a thoracic epidural. It's not suitable for pregnant individuals, those who refuse to participate, have allergies to adhesives/local anesthesia, or conditions that make getting an epidural unsafe like bleeding disorders, infections, high brain pressure, or severe neurological issues.

Inclusion Criteria

I am having surgery with a thoracic epidural for pain relief.

Exclusion Criteria

I have chosen not to participate in this trial.

Pregnancy

I cannot have an epidural due to a bleeding disorder, infection, high brain pressure, or severe nerve disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Catheter fixation using Dermabond, Mastisol, or Grip-Lok, followed by epidural catheter infusion with Bupivacaine and Fentanyl

7 days

Daily monitoring post-operative

Follow-up

Participants are monitored for catheter displacement and skin changes post-treatment

7 days

Daily assessments until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Thoracic Epidural Catheter Fixation Techniques

Trial Overview The study is comparing three ways of securing a thoracic epidural catheter: using Dermabond (a medical glue), Mastisol (an adhesive liquid), and the Grip-Lok fixation bandage. The goal is to see which method keeps the catheter in place most effectively during surgery.

How Is the Trial Designed?

Group I: Dermabond Experimental Treatment 1 Intervention

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Dermabond. The investigator performing the thoracic epidural will distribute the Dermabond at the catheter insertion site in a space no greater than a 2 cm circle around the site. Once the Dermabond is allowed to dry, mastisol will be applied to the surrounding skin and a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia with a goal rate of 6ml/hr.

Group II: Mastisol Active Control 1 Intervention

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Mastisol spray. The investigator performing the epidural placement will distribute Mastisol spray both in close proximity to the catheter insertion site as well as around the insertion site. Once the Mastisol is allowed to dry, a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team with a goal rate of 6ml/hr.

Group III: Grip-lock Active Control 1 Intervention

Catheter fixation will be performed after appropriate placement of a thoracic epidural with a Grip-Lok fixation bandage. The investigator performing the epidural placement will place the fixation bandage one centimeter caudal from the insertion site. Mastisol will be applied to the surrounding skin and a clear Tegaderm will then be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team in the operating room with a goal rate of 6ml/hr.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 83 patients undergoing thoracotomy, using an obtuse angle for thoracic epidural catheter placement resulted in a longer coiling length (7.4 cm) compared to an acute angle (4.9 cm), indicating a significant difference in catheter positioning.

The findings suggest that employing an obtuse approach angle may enhance the effectiveness of epidural catheter placement by reducing the risk of malpositioning and ensuring the catheter reaches the intended level more reliably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The coiling length of thoracic epidural catheters: the influence of epidural approach angle. Ryu, HG., Bahk, JH., Lee, CJ., et al.[2018]

Thoracic epidurals are considered the best option for pain relief after major abdominal and thoracic surgeries, but they have a high failure rate of over 30%, indicating challenges in their placement and maintenance.

This case series highlights the difficulties in accurately identifying the correct vertebral level for thoracic epidural catheter placement when patients are positioned on their sides, which is crucial for effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface Landmarks in the Lateral Decubitus Position Are Unreliable for Thoracic Epidural Catheter Placement: A Case Series. Dobson, SW., Weller, RS., Turner, JD., et al.[2023]

Using real-time ultrasound visualization for placing thoracic epidural catheters significantly improves the accuracy and safety of the procedure, as traditional methods can lead to complications due to anatomical challenges.

In a study where this technique was applied, successful epidural placement was achieved in every patient, and all catheters were effective for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Ultrasound-Assisted Thoracic Epidural Placement: A Feasibility Study of a Novel Technique. Pak, DJ., Gulati, A.[2019]

Thoracic epidural anesthesia is important for patients undergoing lung surgery, but it can lead to neurologic adverse events, although permanent injuries are rare.

This case highlights a serious but uncommon complication: persistent cortical blindness following a test dose of bupivacaine, emphasizing the need for careful monitoring during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent cortical blindness after a thoracic epidural test dose of bupivacaine. Visser, WA., Kolling, JB., Groen, GJ., et al.[2013]

In a study of 200 postoperative patients, the use of the Lockit device for securing epidural catheters resulted in significantly lower rates of catheter migration (3%) compared to tunneled catheters (12%).

Patients using the Lockit device reported less procedural discomfort (only 14% experienced erythema) compared to those with tunneled catheters, where 77% reported significant discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural catheter fixation. A comparison of subcutaneous tunneling versus device fixation technique. Sharma, A., Parasa, SK., Tejvath, K., et al.[2022]

In a study of 121 patients undergoing major surgery, tunneling and suturing epidural catheters significantly reduced the incidence of clinically relevant dislocation compared to those fixed with adhesive tape, with only 1 out of 60 tunneled catheters dislocating more than 20 mm versus 9 out of 61 taped catheters.

Tunneling also showed a trend towards lower bacterial contamination rates, suggesting that this method may enhance both the stability and safety of epidural catheter placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunneling and suture of thoracic epidural catheters decrease the incidence of catheter dislodgement. Sellmann, T., Bierfischer, V., Schmitz, A., et al.[2022]

The study successfully demonstrated a paramedian approach with cephalic angulation for inserting thoracic epidural catheters in 3 dogs, providing effective intra- and postoperative analgesia using a combination of bupivacaine and morphine.

While the technique was generally effective, one dog experienced transient Horner's syndrome, indicating a potential side effect, and another required additional pain management during surgery, highlighting the need for careful monitoring during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic epidural catheter placement using a paramedian approach with cephalad angulation in three dogs. Franci, P., Leece, EA., Corletto, F.[2013]

Thoracic epidural anesthesia is considered the gold standard for pain management during and after surgery due to its reliability and relatively low complication rate when contraindications are followed.

Despite its effectiveness, complications can occur during the procedure, which may lead to serious consequences for patients and require additional treatments, increasing overall morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EnglischerTitel: Epidural anesthesia - complications and side effects]. Schmidt, T., Wenk, M.[2015]

In a study of 167 children aged 5-16 years, the Lockit plus® device was found to significantly reduce epidural catheter migration compared to Micropore™ surgical dressing and Tegaderm™, with migration rates of only 24.1% at 48 hours versus 66.1% for Micropore™.

The mean catheter migration was also lowest in the Lockit plus® group (0.34 cm) compared to Micropore™ (1.22 cm) and Tegaderm™ (0.94 cm), indicating that Lockit plus® provides superior fixation for epidural catheters in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of Micropore™ surgical dressing, Tegaderm™ and Lockit plus® for lumbar epidural catheter fixation in children: a prospective parallel group randomized controlled trial. Anilakumari, D., Singla, D., Agarwal, A., et al.[2023]

In a study of 50 patients comparing two techniques for securing epidural catheters, both the new sutured technique and the traditional tunnelled technique showed similar rates of clinically significant catheter movement, with 32% and 28% respectively.

However, the sutured technique was associated with a significantly higher incidence of erythema at the catheter exit site (12% vs 2%), raising safety concerns despite its comparable efficacy in preventing catheter migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural catheter migration: a comparison of tunnelling against a new technique of catheter fixation. Chadwick, VL., Jones, M., Poulton, B., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03976154

Effects of Fixation Technique On Thoracic Epidural ... The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok ...

2. trialx.com trialx.com/clinical-trials/listings/244803/effects-of-fixation-technique-on-thoracic-epidural-catheter-displacement/?&radius=50

Effects of Fixation Technique On Thoracic Epidural Catheter ... The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok ...

3. withpower.com withpower.com/trial/epidural-catheter-fixation-techniques-for-thoracic-epidural-management-4e781

Epidural Catheter Fixation Techniques for Thoracic ... The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29533260/

The Effectiveness of Applying Soft Tissue Bonding ... Conclusions: Epidural catheter fixation using film dressing combined with 2-ethyl cyanoacrylate adhesive application at 2 sites along the catheter resulted in ...

5. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(17)30901-7/pdf

Thoracic epidural analgesia, a way forward In summary, our results using CON catheters for catheter- ized interscalene, supraclavicular, and femoral nerve blocks demonstrate the CON method's benefits ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03976154/effects-of-fixation-technique-on-thoracic-epidural-catheter-displacement

Effects of Fixation Technique on Thoracic Epidural ... The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6054289/

Optimizing the securement of epidural catheters: an in vitro ... Our study demonstrates a potentially better technique for securement of the epidural catheter insertion site. Furthermore, it demonstrates that ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01402778

Fixation of Thoracic Epidurals Influencing Catheter-related ... A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be ...