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Completed

NCT Number: NCT01560429

Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia 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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PCEA

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.

Other names: CEA

Primary outcomes

  1. Local Anesthetic Consumption

    Time frame: 48 hours postoperatively

    Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.

  2. Anesthetic Consumption (mg)

    Time frame: 4,8,12, 24 and 48 hours postoperatively

    amount of anesthetic consumed was calculated for each group over time.

Secondary outcomes

  1. Worst Pain Scores

    Time frame: 48 hours postoperatively

    worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery

  2. Worst Pain While Coughing

    Time frame: 48 hours postoperatively

    Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2012
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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