A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02056301
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 86
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain score during postoperative days 0-4.

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Drug: Hydromorphone; Drug: Morphine	Phase 4

Detailed Description

Pectus excavatum is a cartilaginous deformity that is the most common congenital anterior chest wall defect in children [1]. Children with this disease process often complain of dyspnea, decreased exercise tolerance, and shortness of breath implying a restrictive pulmonary deficit [2]. Besides the reported physical limitations, patients can also exhibit manifestations of psychological disturbances (poor body image and depression). Surgical repair has been correlated with enhanced quality of life and improvement in body image[3] with recent studies showing improved pulmonary function and cardiac output [4, 5]. Surgery initially introduced by Sauerbruch involved rib cartilage resection and sternal osteotomy. This open procedure was further modified and became [6] known as the Ravitch procedure. This was the mainstay for repair for over 40 years until the introduction of minimally invasive surgery without rib resection by Nuss and colleagues in 1987 [7]. The Nuss repair involves placing an intrathoracic brace through small lateral chest wall incisions aided by thoracoscopy. Similar to bracing the teeth, the Nuss procedure avoids osteotomy or rib cartilage resection [8]. The Nuss procedure is the most common minimally invasive procedure in use today to correct this condition and is the current standard of surgical practice. Complications from Nuss repair can range anywhere from 7% to 25% [9] and can occur for as long as the bar is in place. Pain control remains a major issue in the perioperative period as patients may require weeks to months of oral narcotics before becoming pain-free after correction of the pectus. A prospective multicenter study reported peak pain scores of 8 on a 0-10 scale in the postoperative period and a mean score of 3 at discharge [4]. Postoperative pain after pectus repair has been managed with IV opioids administered by patient controlled analgesia (PCA) devices and by thoracic epidural infusions of combinations of local anesthetics and opioids. It is unclear from published data which method is superior and different tertiary care centers in the USA have a preference for different methods.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Comparison Trial Between Patient Controlled Intravenous Analgesia (PCA) and Epidural Analgesia for Pectus Excavatum Repair
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Apr 10, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patient Controlled Analgesia One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes.	Drug: Morphine; This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
Active Comparator: epidural Catheter The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space.	Drug: Hydromorphone; In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.

Outcome Measures

Primary Outcome Measures

1. Verbal Pain Scale Scores During Postoperative Days 0-4 [Postoperative days 0-4]

   The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain.

Secondary Outcome Measures

1. Total Morphine Equivalent Consumption During Postoperative Days 0-4 [Postoperative days 0-4]

   This outcome measures total amount of morphine administered in mg/kg by post-operative day 0-4. This captures all standard of care opioids delivered via their assigned cohort route (Epidural vs. IV PCA). Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.

2. Rescue Morphine Equivalent Administration During Postoperative Days 0-4 [Postoperative days 0-4]

   This outcome measures the amount of rescue morphine administered due to breakthrough pain in mg/kg by post-operative day 0-4. This captures additional opioids that were administered by a nurse through an IV. Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients age 8- 18 years 2) Patients undergoing minimally invasive pectus excavatum repair via Nuss procedure 3) American Society of Anesthesiology Status I-III

Exclusion Criteria:

• 1. Refusal of epidural catheter 2) Pregnancy 3) Bleeding History 4) Inability to understand how to use the PCA device 5) Medication interfering with blood coagulation

1. Patients allergic to local anesthetics 7) Patient refusal to participate in study
2. Developmental delay

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children't Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: Chris Glover, MD, Baylor College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 24, 2019

More Information

Publications

None provided.

• Responsible Party: Chris Glover, Pediatric Anesthesiologist, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02056301
• Other Study ID Numbers: H31096
• First Posted: Feb 5, 2014
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Funnel Chest; Morphine; Hydromorphone

Study Results

Participant Flow

Arm/Group Title	Patient Controlled Analgesia	Epidural Catheter
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes	The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
Period Title: Overall Study
STARTED	33	29
COMPLETED	31	23
NOT COMPLETED	2	6

Baseline Characteristics

Arm/Group Title	Patient Controlled Analgesia	Epidural Catheter	Total
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes	The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.	Total of all reporting groups
Overall Participants	31	23	54
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	15.7	16.0	15.8
Sex/Gender, Customized (Count of Participants)
Male	26 83.9%	21 91.3%	47 87%
Female	3 9.7%	1 4.3%	4 7.4%
Unknown	2 6.5%	1 4.3%	3 5.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%	23 100%	54 100%
ASA Status (Count of Participants)
ASA I	8 25.8%	7 30.4%	15 27.8%
ASA II	20 64.5%	15 65.2%	35 64.8%
ASA III	1 3.2%	0 0%	1 1.9%
ASA IV	0 0%	0 0%	0 0%
ASA V	0 0%	0 0%	0 0%
ASA VI	0 0%	0 0%	0 0%
Unknown	2 6.5%	1 4.3%	3 5.6%

Outcome Measures

1. Primary Outcome

Title	Verbal Pain Scale Scores During Postoperative Days 0-4
Description	The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain.
Time Frame	Postoperative days 0-4

Outcome Measure Data

Analysis Population Description

Pain scores could not be collected on each post-operative day because some subjects were discharged from the hospital quicker than others.

Arm/Group Title	Patient Controlled Analgesia	Epidural Catheter
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes	The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
Measure Participants	29	21
Post-Operative Day 0	3.69 (1.98)	2.28 (1.63)
Post-Operative Day 1	2.77 (2.19)	1.11 (1.18)
Post-Operative Day 2	2.25 (1.65)	2.14 (1.8)
Post-Operative Day 3	2.69 (1.33)	2.73 (1.85)
Post-Operative Day 4	2.24 (1.52)	2.14 (2.5)

2. Secondary Outcome

Title	Total Morphine Equivalent Consumption During Postoperative Days 0-4
Description	This outcome measures total amount of morphine administered in mg/kg by post-operative day 0-4. This captures all standard of care opioids delivered via their assigned cohort route (Epidural vs. IV PCA). Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
Time Frame	Postoperative days 0-4

Outcome Measure Data

Analysis Population Description

Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others.

Arm/Group Title	Patient Controlled Analgesia	Epidural Catheter
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes	The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
Measure Participants	31	23
Day 0	0.75 (0.34)	0.14 (0.06)
Day 1	0.90 (0.42)	0.23 (0.12)
Day 2	0.67 (0.33)	0.61 (0.34)
Day 3	0.57 (0.36)	0.92 (0.23)
Day 4	0.39 (0.32)	0.45 (0.34)

3. Secondary Outcome

Title	Rescue Morphine Equivalent Administration During Postoperative Days 0-4
Description	This outcome measures the amount of rescue morphine administered due to breakthrough pain in mg/kg by post-operative day 0-4. This captures additional opioids that were administered by a nurse through an IV. Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent.
Time Frame	Postoperative days 0-4

Outcome Measure Data

Analysis Population Description

Total Morphine Equivalent Consumption could not be collected on each post-operative day for every subject because some subjects were discharged from the hospital quicker than others.

Arm/Group Title	Patient Controlled Analgesia	Epidural Catheter
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes	The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
Measure Participants	31	23
Day 0	1.26 (0.89)	0.57 (0.73)
Day 1	0.23 (0.67)	0.26 (0.69)
Day 2	0.13 (0.50)	0.70 (1.15)
Day 3	0.07 (0.26)	0.39 (0.94)
Day 4	0.05 (0.23)	0.10 (0.44)

Adverse Events

Time Frame	Subjects were monitored for adverse events until hospital discharge, up to postoperative day 4.
Arm/Group Title	Patient Controlled Analgesia		Epidural Catheter
Arm/Group Description	One group will have a patient controlled device connected to an intravenous patient controlled analgesia (IV PCA). This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes. Morphine: This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes		The other group will have an epidural catheter inserted under sterile conditions in the thoracic epidural space after anesthesia has been induced. This will be connected to a patient controlled epidural analgesia (PCEA) device for postoperative pain control that works in a similar manner except the medication (a combination of local anesthetics and hydromorphone) will be administered in the thoracic epidural space. Hydromorphone: In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
All Cause Mortality
	Patient Controlled Analgesia		Epidural Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/29 (0%)
Serious Adverse Events
	Patient Controlled Analgesia		Epidural Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/33 (3%)		0/29 (0%)
Surgical and medical procedures
Surgical Complications	1/33 (3%)	1	0/29 (0%)	1
Other (Not Including Serious) Adverse Events
	Patient Controlled Analgesia		Epidural Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/33 (9.1%)		3/29 (10.3%)
Surgical and medical procedures
Epidural Related	3/33 (9.1%)	3	3/29 (10.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.