Acute Post-thoracotomy Pain
Conditions
Keywords
anesthesia and analgesia, Epidural Anesthesia, administration schedules, drug
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).
Interventions
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.
PROCEDUREContinuous 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.
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Anesthetic Consumption | 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. |
| Anesthetic Consumption (mg) | 4,8,12, 24 and 48 hours postoperatively | amount of anesthetic consumed was calculated for each group over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Pain Scores | 48 hours postoperatively | worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery |
| Worst Pain While Coughing | 48 hours postoperatively | Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy |
Countries
Canada
Participant flow
Recruitment details
Patients were enrolled prior to thoracotomy. 52 patients were randomized to receive PCEA (n=26) or CEA (n=26).
Participants by arm
| Arm | Count |
|---|---|
| Patient-controlled Epidural Analgesia All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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 the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. | 23 |
| Continuous Epidural Analgesia All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. 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. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour. | 20 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 6 |
Baseline characteristics
| Characteristic | Patient-controlled Epidural Analgesia | Continuous Epidural Analgesia | Total |
|---|---|---|---|
| Age, Continuous >=65 years | 70.9 years STANDARD_DEVIATION 4.1 | 70.6 years STANDARD_DEVIATION 3.1 | 70.8 years STANDARD_DEVIATION 3.6 |
| Age, Continuous Between 18 and 65 years | 60.8 years STANDARD_DEVIATION 5.2 | 56.7 years STANDARD_DEVIATION 5.9 | 58 years STANDARD_DEVIATION 5.9 |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 6.1 | 62.7 years STANDARD_DEVIATION 8.5 | 65.6 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Canada | 23 participants | 20 participants | 43 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
Anesthetic Consumption (mg)
amount of anesthetic consumed was calculated for each group over time.
Time frame: 4,8,12, 24 and 48 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-controlled Epidural Analgesia | Anesthetic Consumption (mg) | 158.9 mg | Standard Error 73.5 |
| Continuous Epidural Analgesia | Anesthetic Consumption (mg) | 181.5 mg | Standard Error 73.5 |
Primary
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.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-controlled Epidural Analgesia | Local Anesthetic Consumption | 1505.39 ug | Standard Error 339.43 |
| Continuous Epidural Analgesia | Local Anesthetic Consumption | 1862.16 ug | Standard Error 493.85 |
Secondary
Worst Pain Scores
worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery
Time frame: 48 hours postoperatively
Secondary
Worst Pain While Coughing
Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy
Time frame: 48 hours postoperatively