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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):
Dr. Vidur Shyam, Queen's University
ClinicalTrials.gov Identifier:
NCT01560429
First received: March 6, 2012
Last updated: June 9, 2016
Last verified: June 2016
  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 52 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively all patients were titrated on continuous epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined randomization (either remained on continuous epidural infusion or they were switched to receive 2/3 of the stabilized background dose via continuous epidural infusion with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was consumption of local anaesthetics/opioids. 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 48 hours following thoracotomy administered either through CEA or PCEA.

  • Anesthetic Consumption (mg) [ Time Frame: 4,8,12, 24 and 48 hours postoperatively ] [ Designated as safety issue: No ]
    amount of anesthetic consumed was calculated for each group over time.


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 numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy


Enrollment: 52
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
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
Procedure: Patient controlled epidural analgesia
Continuous epidural infusion rates were set to maintain pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in the post anesthesia care unit (PACU) following thoracotomy. Once stabilized patients were switched to Patient controlled epidural analgesia (PCEA) which meant they continued to receive 2/3rds of the dose as continuous background epidural infusions but they had the option to receive the remaining 1/3rd dosage via PCEA.
Other Name: PCEA
Active Comparator: continuous epidural analgesia
An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion rate until stable pain scores of ≤ 3 were reached while in PACU (as described in the PCEA group). Once stable, they were allocated to their preoperatively determined randomization assignment which for the CEA group meant they remained on the continuous background epidural infusion rate previously determined to maintain pain scores ≤ 3 while in PACU. Rescue analgesia was available as needed.
Procedure: Continuous epidural analgesia
The continuous epidural analgesia (CEA) infusion rates were titrated to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in post-anesthesia care unit (PACU) (as described for the PCEA group above). Those allocated to the CEA group remained on the same continuous epidural analgesia infusion which maintained the pain scores at ≤ 3.
Other Name: CEA

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

Responsible Party: Dr. Vidur Shyam, Principal Investigator, 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
Results First Received: June 12, 2013
Last Updated: June 9, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016