Pain Management for Pectus Excavatum Repair

NCT00413582 | Completed Results

• 1 other identifier: 06 08 128
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Pectus Excavatum; Bar Repair; Pain Control; Pectus Excavatum Repair

Outcome Measures

Primary Outcomes (1)

• Length of Hospitalization

  1 week

Secondary Outcomes (1)

• Time in the Operating Room

  1 week

Study Arms (2)

1

ACTIVE COMPARATOR

Epidural analgesia

Drug: Epidural Analgesia

2

EXPERIMENTAL

IV narcotic analgesia

Drug: Patient-Controlled IV Analgesia

Interventions

Epidural Analgesia DRUG

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.

1

Patient-Controlled IV Analgesia DRUG

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.

2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing a pectus excavatum repair with bar placement.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Funnel Chest; Agnosia

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Shawn D. St. Peter, MD
• Organization: Children's Mercy Hospital

sspeter@cmh.edu

816-983-6479

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 20, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 16, 2012
• Results First Posted: January 16, 2012

Record last verified: 2011-12

Locations

US (1)