Caudal Versus Rectus Sheath Study

NCT01394523 | Terminated Phase 2 Results

• 1 other identifier: IRB11-00363
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia

Conditions

Umbilical Hernia

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Score

  Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.

  30 minutes

Study Arms (3)

Caudal epidural

ACTIVE COMPARATOR

The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.

Drug: Bupivacaine

Rectus sheath

ACTIVE COMPARATOR

The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.

Drug: Bupivacaine

Local

ACTIVE COMPARATOR

The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

0.25% or 0.5%

Caudal epidural; Local; Rectus sheath

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II
• Weight less than or equal to 20 kg
• Presenting for repair of umbilical hernia

You may not qualify if:

• ASA physical status \> II
• Weight greater than 20 kg
• Co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients having concomitant procedures (circumcision, orchiopexy, etc.)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Hernia, Umbilical

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Tarun Bhalla, MD
• Organization: Nationwide Children's Hospital

Tarun.Bhalla@nationwidechildrens.org

6147224200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 19, 2017
• Results First Posted: December 19, 2017

Record last verified: 2017-11

Locations

US (1)