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PainNCT00754195

Insertion Distance of Thoracic Epidural Catheters in the Context of Thoracotomy Procedures.

A study testing Thoracic epidural catheter in people with Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to compare thoracic epidural catheter insertion distances, in order to determine which is the best for pain relief following a thoracotomy. HYPOTHESIS : 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Thoracic epidural catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCanada
Study dates
Sep 2008to Jun 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years and older undergoing an elective thoracotomy.

Who cannot join

  • Infection or sepsis
  • Coagulopathy
  • Hypovolemia
  • Allergy to local anesthetics
  • Neuropathy that could affect study assessments
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia in the Context of Thoracotomy Procedures.

This study is designed to compare thoracic epidural catheter insertion distances, in order to determine which is the best for pain relief following a thoracotomy.

HYPOTHESIS :

  1. The quality of epidural analgesia upon coughing one hour following the end of surgery will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3 and 5 cm.
  2. The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.
Read the detailed description

Thoracic surgery such as posterolateral thoracotomy is associated with severe postoperative pain. Pain control is particularly important, as adequate analgesia allows rapid mobilisation and prevents complications related to immobility. Over the last years, thoracic epidural analgesia has become increasingly popular and is now considered the gold standard after thoracotomy. Thoracic epidural analgesia improves pain relief and also significantly decreases the incidence of morbidity and mortality following pulmonary resection. It also reduces the length of stay in the hospital and long-term pain 6 months after surgery. This method is now offered to a majority of patients undergoing a thoracotomy in our hospital.

The placement of a catheter in the thoracic epidural space remains a challenge for the anesthesiologist. Suboptimal placement of the catheter within the epidural space can result in inadequate pain relief. The distance at which the catheter must be advanced in the thoracic epidural space remains unknown. Insertion distance could influence the initial quality and distribution of sensory blockade, its duration, or both. Therefore, this study is designed to compare three catheter insertion distances, in order to help determine which is best for pain relief after a thoracotomy.

Methods :

  1. Insertion of the epidural catheter : Patients will be randomly assigned to the following groups :
  • Group 1 : 3 cm insertion
  • Group 2 : 5 cm insertion
  • Group 3 : 7 cm insertion The anesthesiologist will insert the epidural catheter at T6-T7 before the induction of anesthesia for surgery. The usual medication will be used to make catheter installation comfortable. Standard non-invasive monitoring will be used. Correct placement of the epidural catheter will be assessed by infusing a bolus of 5 mL of lidocaine 1.5% with epinephrine 1 : 200,000. After induction of anesthesia and after placing the patient in the lateral decubitus position, the epidural infusion (bupivacaine 0.1% and fentanyl 2 mcg/mL) will be started at a rate of 0.1 mL/kg/h. Adjustments will be made between 4 to 16 mL/h with boluses of 0.1 mL/kg (maximum 7 mL) of solution as needed. Surgery will be performed under general anesthesia using a standardised protocol.
  1. Post-operative analgesia : Pain will be assessed using a verbal numeric rating scale (NRS), where 0 refers to " no pain " and 10 refers to " the worst pain imaginable ". Pain at the surgical site and post-thoracotomy shoulder pain will be assessed separately. Post-thoracotomy shoulder pain will be treated with acetaminophen 975 mg every 6 hours and nonsteroidal antiinflammatory drugs (NSAIDs) or opioids as needed. Patients experiencing moderate to severe pain at the surgical incision site will receive a bolus of 0.1 mL/kg (maximum 7 mL) of epidural solution, and the infusion rate will be increased in 2 mL/h increments, to a maximum infusion rate of 16 mL/h. The infusion rate will be adjusted to maintain a pain score at the surgical site of 3 or less on the numeric rating scale. One hour after arrival in the recovery room, NRS during cough, at rest, and upon palpation, as well as loss of cold sensation will be assessed by a member of the research team who is blinded to the patient's group assignment. Total bupivacaine and morphine doses will be recorded.
  2. Follow-up

At 24 hours after surgery, NRS during cough, at rest, and upon palpation, as well as loss of cold sensation, will be assessed by a member of the research team who is blinded to the patient's group assignment. Total bupivacaine and morphine doses will be recorded. Catheter distance at the skin will be verified for displacement.

Conditions
Pain
Being tested
Thoracic epidural catheter
Keywords
Thoracotomy
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic epidural catheterOther

    Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.

Study groups in NCT00754195
Study groupRoleWhat they receive
1Active comparatorInsertion distance of thoracic epidural catheter: 3 cm
Receives: Other: Thoracic epidural catheter
2Active comparatorInsertion distance of thoracic epidural catheter: 5 cm
Receives: Other: Thoracic epidural catheter
3Active comparatorInsertion distance of thoracic epidural catheter: 7 cm
Receives: Other: Thoracic epidural catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of pain relief during cough

    Measured: At one hour and 24 hours after surgery

Secondary outcomes (5)
  1. Quality of pain relief at rest

    Measured: At one hour and 24 hours after surgery

  2. Proportion of failed epidurals

    Measured: At one hour and 24 hours after surgery

  3. Wound palpation pain

    Measured: At one hour and 24 hours after surgery

  4. Loss of cold sensation around the wound

    Measured: At one hour and 24 hours after surgery

  5. Cumulative bupivacaine and morphine consumption

    Measured: At one hour and 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754195
Sponsor's protocol ID
08.071
Status last verified
Feb 2015
First submitted
15 Sep 2008
Last updated
23 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic epidural catheter in people with Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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 1 inclusion and 6 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Quality of pain relief during cough (time frame: At one hour and 24 hours after surgery). 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 23 Feb 2015.

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