Pain Following Thoracotomy Surgery
Conditions
Keywords
Thoracotomy, Pain
Brief summary
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.
Detailed description
In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.
Interventions
DRUGEpidural
DRUGIntercostal Bupivicaine (Exparel)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).
Exclusion criteria
* Planned chest wall resection or abdominal incision and/or gastroesophageal surgery; * Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution); * Daily opioid therapy; * Current gabapentin or pregabalin therapy; * Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement; * Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals; * Severe hepatic, renal or cardiovascular disorders. * Women who are pregnant will not be included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores With Cough on First Postoperative Day | In the morning (8 am) on first postoperative day | Pain with cough documented using the numerical rating scale pain scores (0-10) |
| Pain Scores With Cough on the Second Postoperative Day | In the morning (8 am) on the second postoperative day | Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores at Rest in the Morning on the First Postoperative Day | Each morning for two days postoperative | NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine. |
| Pain Scores at Rest on the Second Postoperative Day | Each morning for two days postoperative | NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr. | 45 |
| Intercostal Bupivicaine (Exparel) In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered. | 39 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not proceed to open thoracotomy | 7 | 3 |
| Overall Study | Physician Decision | 0 | 4 |
| Overall Study | Technical problem with injection | 1 | 3 |
Baseline characteristics
| Characteristic | Epidural | Intercostal Bupivicaine (Exparel) | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 12.5 | 62.1 years STANDARD_DEVIATION 10.8 | 61.9 years STANDARD_DEVIATION 11.7 |
| Body Mass Index | 29.5 kg/m2 STANDARD_DEVIATION 6.1 | 28.8 kg/m2 STANDARD_DEVIATION 7.4 | 29.2 kg/m2 STANDARD_DEVIATION 6.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Sex Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Sex Male | 26 Participants | 18 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 46 | 3 / 39 |
| other Total, other adverse events | 3 / 46 | 0 / 39 |
| serious Total, serious adverse events | 5 / 46 | 5 / 39 |
Outcome results
Primary
Pain Scores With Cough on First Postoperative Day
Pain with cough documented using the numerical rating scale pain scores (0-10)
Time frame: In the morning (8 am) on first postoperative day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural | Pain Scores With Cough on First Postoperative Day | 6.1 units on a scale | Standard Deviation 2.7 |
| Intercostal Bupivicaine (Exparel) | Pain Scores With Cough on First Postoperative Day | 6.9 units on a scale | Standard Deviation 2.4 |
p-value: 0.14290% CI: [-0.1, 1.8]t-test, 2 sided
Primary
Pain Scores With Cough on the Second Postoperative Day
Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Time frame: In the morning (8 am) on the second postoperative day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural | Pain Scores With Cough on the Second Postoperative Day | 5.2 score on a scale | Standard Deviation 2.1 |
| Intercostal Bupivicaine (Exparel) | Pain Scores With Cough on the Second Postoperative Day | 6.0 score on a scale | Standard Deviation 1.9 |
p-value: 0.10190% CI: [0.4, 1.9]t-test, 2 sided
Secondary
Pain Scores at Rest in the Morning on the First Postoperative Day
NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Time frame: Each morning for two days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural | Pain Scores at Rest in the Morning on the First Postoperative Day | 2.9 NRS pain score on a scale from 0-10 | Standard Deviation 2 |
| Intercostal Bupivicaine (Exparel) | Pain Scores at Rest in the Morning on the First Postoperative Day | 4.0 NRS pain score on a scale from 0-10 | Standard Deviation 2.2 |
p-value: 0.01490% CI: [0.4, 1.9]t-test, 2 sided
Secondary
Pain Scores at Rest on the Second Postoperative Day
NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.
Time frame: Each morning for two days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural | Pain Scores at Rest on the Second Postoperative Day | 2.8 NRS pain scores on a scale from 0-10 | Standard Deviation 1.9 |
| Intercostal Bupivicaine (Exparel) | Pain Scores at Rest on the Second Postoperative Day | 3.2 NRS pain scores on a scale from 0-10 | Standard Deviation 1.6 |
p-value: 0.37590% CI: [-0.3, 1]t-test, 2 sided