Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
NCT Number: NCT01560429
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).
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Kingston, Ontario, K7L 2V7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: PCEA
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 names: CEA
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.
Time frame: 4,8,12, 24 and 48 hours postoperatively
amount of anesthetic consumed was calculated for each group over time.
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
Time frame: 48 hours postoperatively
Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy
Queen's University
Other
Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02397603
Acute Post-thoracotomy Pain
Giza, Egypt
View Trial DetailsNCT04401007
Agnosia, Nervous System Diseases
Toronto, Ontario, Canada
View Trial DetailsNCT07736118
Agnosia, Behavior
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT07145788
Agnosia, Chronic Pain
Stuttgart, Auerbachstraße 112, Germany
View Trial Details