Phase 4
N=52
Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
Acute Post-thoracotomy Pain
Bottom Line
View on ClinicalTrials.gov: NCT01560429 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Local Anesthetic Consumption — 1505.39; 1862.16 ug
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Patient controlled epidural analgesia (Procedure); Continuous epidural analgesia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Anesthetic Consumption |
1505.39; 1862.16 | — |
| PRIMARY Anesthetic Consumption (mg) |
158.9; 181.5 | — |
| SECONDARY Worst Pain Scores |
— | — |
| SECONDARY Worst Pain While Coughing |
— | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01560429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.