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

Phase 4
Completed
Conditions
Acute Post-thoracotomy Pain
Interventions
Procedure: Continuous epidural analgesia
Procedure: Patient controlled epidural analgesia
Registration Number
NCT01560429
Lead Sponsor
Queen's University
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
continuous epidural analgesiaContinuous epidural analgesiaAn 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.
Patient controlled epidural analgesiaPatient controlled epidural analgesiaAn 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.
Primary Outcome Measures
NameTimeMethod
Anesthetic Consumption (mg)4,8,12, 24 and 48 hours postoperatively

amount of anesthetic consumed was calculated for each group over time.

Local Anesthetic Consumption48 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.

Secondary Outcome Measures
NameTimeMethod
Worst Pain While Coughing48 hours postoperatively

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

Worst Pain Scores48 hours postoperatively

worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 \& 48 hours following surgery

Trial Locations

Locations (1)

Kingston General Hospital

🇨🇦

Kingston, Ontario, Canada

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