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

NCT01560429 | Completed Phase 4 Results

• 1 other identifier: ANAE-147-08
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Post-thoracotomy Pain

Keywords

anesthesia and analgesia; Epidural Anesthesia; administration schedules, drug

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Worst Pain Scores

  48 hours postoperatively

• Worst Pain While Coughing

  48 hours postoperatively

Study Arms (2)

Patient controlled epidural analgesia

EXPERIMENTAL

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 analgesia

ACTIVE COMPARATOR

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

Interventions

Patient controlled epidural analgesia PROCEDURE

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.

Also known as: PCEA

Patient controlled epidural analgesia

Continuous epidural analgesia PROCEDURE

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.

Also known as: CEA

continuous epidural analgesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• American Society of Anesthesiologist's (ASA) Physical Status I-III
• Body Mass Index (BMI) \< 40
• Able to use a PCEA device

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Vidur Shyam
• Organization: Queen's University

shyamv@kgh.kari.net

(613) 548-7827

Study Officials

• Vidur Shyam, MBBS, FRCPC

  Queen's University & Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 22, 2012
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 21, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)