Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
Condition: Acute Post-thoracotomy Pain
Intervention: Patient controlled epidural analgesia; Continuous epidural analgesia
Intervention description: 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.; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: anesthesia and analgesia; Epidural Anesthesia; administration schedules, drug

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.