Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
|ClinicalTrials.gov Identifier: NCT01560429|
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Post-thoracotomy Pain||Procedure: Patient controlled epidural analgesia Procedure: Continuous epidural analgesia||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
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
- Local Anesthetic Consumption [ Time Frame: 48 hours postoperatively ]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 ]amount of anesthetic consumed was calculated for each group over time.
- Worst Pain Scores [ Time Frame: 48 hours postoperatively ]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 ]Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560429
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator:||Vidur Shyam, MBBS, FRCPC||Queen's University & Kingston General Hospital|