Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01494272
Other study ID # 5110235
Secondary ID
Status Completed
Phase N/A
First received December 15, 2011
Last updated November 23, 2015
Start date June 2012
Est. completion date May 2015

Study information

Verified date November 2015
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 2015
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Months to 2 Years
Eligibility Inclusion Criteria:

1. Age 2 months to 2 years

2. Weight 25kg or less

3. ASA class 1, 2, 3

4. Elective inguinal herniorrhaphy or orchiopexy

Exclusion Criteria:

1. Contraindications to caudal epidural analgesia

2. parent's refusal

3. skeletal or spinal cord anomaly

4. coagulopathy

5. infection at the insertion site

6. ongoing bacteremia

7. allergy to ropivacaine

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Loma Linda University Medical Center Loma Linda California
United States Loma Linda University Outpatient Surgery Center Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usage of pain medications over 24 hours No
Secondary Pain scores At various intervals for first 24 hours No
See also
  Status Clinical Trial Phase
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT04272320 - The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair N/A
Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
Recruiting NCT03856710 - Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair N/A
Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01679353 - Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
Recruiting NCT01450345 - Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain Phase 3
Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
Completed NCT01000116 - Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP) N/A
Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMeshâ„¢ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A