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CompletedNCT00754195Updated Feb 23, 2015

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

An interventional study of Thoracic epidural catheter in Pain, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-23.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

  2. 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.

  3. 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.

02

Conditions studied

  • Pain

Keywords

  • Thoracotomy
03

In context

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Infection or sepsis
  • Coagulopathy
  • Hypovolemia
  • Allergy to local anesthetics
  • Neuropathy that could affect study assessments
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    1

    Insertion distance of thoracic epidural catheter: 3 cm

    Other: Thoracic epidural catheter

  • Active comparator
    2

    Insertion distance of thoracic epidural catheter: 5 cm

    Other: Thoracic epidural catheter

  • Active comparator
    3

    Insertion distance of thoracic epidural catheter: 7 cm

    Other: Thoracic epidural catheter

Interventions

  • OtherThoracic epidural catheter

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

06

What researchers measure

Primary outcomes

  1. Quality of pain relief during cough

    Time frame: At one hour and 24 hours after surgery

Secondary outcomes

  1. Quality of pain relief at rest

    Time frame: At one hour and 24 hours after surgery

  2. Proportion of failed epidurals

    Time frame: At one hour and 24 hours after surgery

  3. Wound palpation pain

    Time frame: At one hour and 24 hours after surgery

  4. Loss of cold sensation around the wound

    Time frame: At one hour and 24 hours after surgery

  5. Cumulative bupivacaine and morphine consumption

    Time frame: At one hour and 24 hours after surgery

07

Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
    Montreal, Quebec H2L 4M1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00754195
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Sep 17, 2008
Start date
Sep 2008
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Feb 23, 2015

Study contacts

Stephan R Williams, MD, PhD
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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