Postoperative Pain
Conditions
Keywords
Pectus Excavatum, Bar Repair, Pain Control, Pectus Excavatum Repair
Brief summary
The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair. The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort. The primary outcome variable is length of hospitalization after the intervention.
Detailed description
This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study. Power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. The primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. One group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. The other groups will receive patient controlled intravenous systemic analgesia (PCA). Both groups will have the same management algorithm. All data will be analyzed on intention-to-treat basis.
Interventions
Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max 5mg) and/or fentanyl 0.5 - 2 mcg/kg IV for comfort during the procedure. Once the epidural is placed, the patient will be positioned for surgery. The epidural catheter will be initially bolused with 0.3ml/kg of ropivacaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivacaine 0.10%, fentanyl 2mcg/ml and clonidine 1.5mcg/ml will be initiated immediately at the rate of 0.3ml/kg/hr (max 10ml/hr). Intraoperatively, patients will receive intravenous fentanyl if indicated.
In the PCA arm, patients will receive fentanyl (3-6 mcg/kg) at anesthesia induction. Additional fentanyl may be administered intraoperatively as indicated. Patients who are \> 35 Kg. (in keeping with current FDA approved labeling) will receive a clonidine 0.1 mg/day transdermal patch to the deltoid immediately after induction of anesthesia. Subjects in the epidural arm also receive clonidine. Upon arrival to the post anesthesia care unit, patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose). An additional hydromorphone dose (8mcg/kg) will be available every 2 hours for pain scores of \> 4/10 throughout the duration of PCA use.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients undergoing a pectus excavatum repair with bar placement.
Exclusion criteria
* Open repair * Re-Do operation * Known allergy to a pain medication in the protocol * Existing contraindications to epidural catheter placement * Requirement for 2 bars to be placed (rare) * Inadequate baseline cognitive function to understand/respond to VAS questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Hospitalization | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Time in the Operating Room | 1 week |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from patients undergoing pectus excavatum repair.
Pre-assignment details
All patients who consented were enrolled
Participants by arm
| Arm | Count |
|---|---|
| Epidural Group Epidural analgesia arm of study | 55 |
| PCA Group IV narcotic analgesia arm of study | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | PCA Group | Epidural Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 53 Participants | 49 Participants | 102 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 6 Participants | 8 Participants |
| Age Continuous | 13.55 years STANDARD_DEVIATION 2.91 | 15.3 years STANDARD_DEVIATION 2.84 | 14.43 years STANDARD_DEVIATION 2.99 |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 28 Participants |
| Sex: Female, Male Male | 37 Participants | 45 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Length of Hospitalization
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Group | Length of Hospitalization | 4.54 days | Standard Deviation 1.01 |
| PCA Group | Length of Hospitalization | 4.25 days | Standard Deviation 1 |
Time in the Operating Room
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Group | Time in the Operating Room | 1.97 hours | Standard Deviation 0.35 |
| PCA Group | Time in the Operating Room | 1.58 hours | Standard Deviation 0.33 |