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

Acute Post-thoracotomy Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560429
• Other study ID #: ANAE-147-08
• Secondary ID: ANAE-147-08
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: March 21, 2012
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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 47 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively patients were randomized to receive epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) for 48 hours postoperatively via PCEA (n= 24) or CEA (n=23). CEA infusion rates were titrated to achieve pain scores ≤ 3 out of 10 (numeric rating scale (NRS)) in the recovery room. PCEA parameters were adjusted to allow an equivalent dose per hour. The primary outcome was consumption of local anaesthetic/opioid. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Post-thoracotomy Pain

Intervention

Procedure:
• Patient controlled epidural analgesia
CEA infusion rates were set when pain scores of = 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores = 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.
• Continuous epidural analgesia
The CEA infusion rates were set when pain scores of = 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. PCEA parameters were adjusted to allow an equivalent dose per hour. Use of hydromorphone 20 mcg/ml and bupivacaine 1 mg/ml (20 and 1) or hydromorphone 10 mcg/ml and bupivacaine 2 mg/ml (10 and 2) was permitted to achieve pain scores = 3. Rescue boluses of 0.25% bupivacaine of 3 to 5 cc to a maximum of 10 cc were also permitted to achieve pain scores of less than 3 in PACU. Total consumption includes rescue medications as well as any switch in anesthetic concentration.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local anesthetic consumption	Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 4, 8, 12, 24 and 48 hours following thoracotomy administered either through CEA or PCEA.	48 hours postoperatively	No
Secondary	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	No
Secondary	Worst pain while coughing	Worst pain on a numberical rating scale(0-10 worst) at 24 and 48 horus following thoracotomy	48 hours postoperatively	No