Caudal Versus Rectus Sheath Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Efficacy After Umbilical Hernia Repair in Children

NCT00578136

Umbilical Hernia

COMPLETED NA

Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair

NCT00836134

Pain

COMPLETED NA

Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair

NCT02341144

Pain, Postoperative

COMPLETED NA

Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair

NCT03041948

Hernia, Inguinal Pain, Postoperative

UNKNOWN NA

Analgesia in Children Using Caudal Epidural Ropivacaine

NCT01494272

Inguinal Hernia Circumcision

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Umbilical Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caudal epidural

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

Rectus sheath

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

Local

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

0.25% or 0.5%

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No