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Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01560429
First received: March 6, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural anesthesia (PCEA) is more effective but little research has compared the two methods following thoracotomy. The current randomized, prospective clinical investigation did just this. Following institutional ethics approval 47 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively patients were randomized to receive epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) for 48 hours postoperatively via PCEA (n= 24) or CEA (n=23). CEA infusion rates were titrated to achieve pain scores ≤ 3 out of 10 (numeric rating scale (NRS)) in the recovery room. PCEA parameters were adjusted to allow an equivalent dose per hour. The primary outcome was consumption of local anaesthetic/opioid. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).


Condition Intervention Phase
Acute Post-thoracotomy Pain
Procedure: Patient controlled epidural analgesia
Procedure: Continuous epidural analgesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Local anesthetic consumption [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 4, 8, 12, 24 and 48 hours following thoracotomy administered either through CEA or PCEA.


Secondary Outcome Measures:
  • worst pain scores [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery

  • Worst pain while coughing [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    Worst pain on a numberical rating scale(0-10 worst) at 24 and 48 horus following thoracotomy


Enrollment: 74
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient-controlled epidural analgesia
The patient has an epidural catheter cited preoperatively so patient controlled epidural analgesics can be administered postoperatively.
Procedure: Patient controlled epidural analgesia
CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores ≤ 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.
Procedure: Continuous epidural analgesia
The CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores ≤ 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.
Active Comparator: Continuous epidural analgesia
The patient is cited with an epidural catheter preoperatively to allow for continuous epidural analgesia to be administered postoperatively.
Procedure: Patient controlled epidural analgesia
CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores ≤ 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.
Procedure: Continuous epidural analgesia
The CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores ≤ 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years of age
  • American Society of Anesthesiologist's (ASA) Physical Status I-III
  • Body Mass Index (BMI) < 40
  • Able to use a PCEA device

Exclusion Criteria:

  • Intolerance/hypersensitivity to agents used in the study
  • Contraindication to epidural placement
  • Current alcohol/substance abuse
  • Chronic pain condition requiring chronic analgesic
  • BMI ≥ 40 or body weight less than 50kg.
  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: NCT01560429

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Vidur Shyam, MBBS, FRCPC Queen's University & Kingston General Hospital
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01560429     History of Changes
Other Study ID Numbers: ANAE-147-08, ANAE-147-08
Study First Received: March 6, 2012
Last Updated: March 21, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Queen's University:
anesthesia and analgesia
Epidural Anesthesia
administration schedules, drug

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014