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| ID | Type | Description | Link |
|---|---|---|---|
| ANAE-147-08 | Other Identifier | Queens University REB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient controlled epidural analgesia | Experimental | 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. |
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| continuous epidural analgesia | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient controlled epidural analgesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Anesthetic Consumption | Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA. | 48 hours postoperatively |
| Anesthetic Consumption (mg) | amount of anesthetic consumed was calculated for each group over time. | 4,8,12, 24 and 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Pain Scores | worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery | 48 hours postoperatively |
| Worst Pain While Coughing | Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vidur Shyam, MBBS, FRCPC | Queen's University & Kingston General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
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Patients were enrolled prior to thoracotomy. 52 patients were randomized to receive PCEA (n=26) or CEA (n=26).
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient-controlled Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA) |
| FG001 | Continuous Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient-controlled Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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 the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Anesthetic Consumption | Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA. | Posted | Mean | Standard Error | ug | 48 hours postoperatively |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient-controlled Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vidur Shyam | Queen's University | (613) 548-7827 | shyamv@kgh.kari.net |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Continuous epidural analgesia | Procedure | 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. |
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| 48 hours postoperatively |
| BG001 | Continuous Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Continuous Epidural Analgesia |
All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized. |
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| Secondary | Worst Pain Scores | worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery | Not Posted | 48 hours postoperatively |
| Secondary | Worst Pain While Coughing | Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy | Not Posted | 48 hours postoperatively |
| Primary | Anesthetic Consumption (mg) | amount of anesthetic consumed was calculated for each group over time. | Posted | Mean | Standard Error | mg | 4,8,12, 24 and 48 hours postoperatively |
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| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Continuous Epidural Analgesia | All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. | 0 | 20 | 0 | 20 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |