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

Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.

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).

Study Overview

• Status: Completed
• Conditions: Acute Post-thoracotomy Pain
• Intervention / Treatment: Procedure: Patient controlled epidural analgesia; Procedure: Continuous epidural analgesia

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient controlled epidural analgesia; 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.	Procedure: Patient controlled epidural analgesia; 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
Active Comparator: continuous epidural analgesia; 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.	Procedure: Continuous epidural analgesia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Vidur Shyam, MBBS, FRCPC, Queen's University & Kingston General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Epidural Anesthesia; anesthesia and analgesia; administration schedules, drug
• Other Study ID Numbers: ANAE-147-08 (Other Identifier: Queens University REB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO