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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00754195
First received: September 15, 2008
Last updated: February 19, 2015
Last verified: February 2015
  Purpose

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.

Condition Intervention
Pain
Other: Thoracic epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia in the Context of Thoracotomy Procedures.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Quality of pain relief during cough [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of pain relief at rest [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]
  • Proportion of failed epidurals [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]
  • Wound palpation pain [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]
  • Loss of cold sensation around the wound [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]
  • Cumulative bupivacaine and morphine consumption [ Time Frame: At one hour and 24 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Insertion distance of thoracic epidural catheter: 3 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
Active Comparator: 2
Insertion distance of thoracic epidural catheter: 5 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.
Active Comparator: 3
Insertion distance of thoracic epidural catheter: 7 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infection or sepsis
  • Coagulopathy
  • Hypovolemia
  • Allergy to local anesthetics
  • Neuropathy that could affect study assessments
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754195

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephan R Williams, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00754195     History of Changes
Other Study ID Numbers: 08.071
Study First Received: September 15, 2008
Last Updated: February 19, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Thoracotomy

ClinicalTrials.gov processed this record on March 03, 2015