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Pain Management for Pectus Excavatum Repair

Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00413582
Enrollment
110
Registered
2006-12-20
Start date
2006-10-31
Completion date
2010-10-31
Last updated
2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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

DRUGEpidural Analgesia

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.

DRUGPatient-Controlled IV Analgesia

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

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

MeasureTime frame
Length of Hospitalization1 week

Secondary

MeasureTime frame
Time in the Operating Room1 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

ArmCount
Epidural Group
Epidural analgesia arm of study
55
PCA Group
IV narcotic analgesia arm of study
55
Total110

Baseline characteristics

CharacteristicPCA GroupEpidural GroupTotal
Age, Categorical
<=18 years
53 Participants49 Participants102 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants6 Participants8 Participants
Age Continuous13.55 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 participants55 participants110 participants
Sex: Female, Male
Female
18 Participants10 Participants28 Participants
Sex: Female, Male
Male
37 Participants45 Participants82 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Length of Hospitalization

Time frame: 1 week

ArmMeasureValue (MEAN)Dispersion
Epidural GroupLength of Hospitalization4.54 daysStandard Deviation 1.01
PCA GroupLength of Hospitalization4.25 daysStandard Deviation 1
Secondary

Time in the Operating Room

Time frame: 1 week

ArmMeasureValue (MEAN)Dispersion
Epidural GroupTime in the Operating Room1.97 hoursStandard Deviation 0.35
PCA GroupTime in the Operating Room1.58 hoursStandard Deviation 0.33

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026