Appendicitis Clinical Trial
Official title:
A Randomized Comparison of Ultrasound Guided Bilateral Rectus Sheath Block and Local Anesthetic Infiltration for Postoperative Pain Control in Children With Acute Appendicitis
Verified date | July 2015 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
In this research study, the investigators are trying to find out which of the two methods of injecting local anesthetics (at the site of the belly button cut or by ultrasound guided rectus sheath block) will provide better pain relief and less need for pain medication after surgery in children undergoing single incision laparoscopic appendectomy.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 1) Acute appendicitis (2) Age 6 - 17 years (3) American Society of Anesthesiologists Physical Status I - III (4) Patients undergoing SILA procedure performed by a single pediatric surgeon (Dr. Ashwin P. Pimpalwar) (5) Patients judged by parents, physicians and other caretakers as being capable of using the patient controlled analgesia (PCA) device. Exclusion Criteria: - 1) Patients who are not scheduled to undergo the procedure of SILA. (2) Patients with allergies to local anesthetics (3) Patients who do not understand or cannot use the pain rating scale because of developmental delay, language or other issues. (4) Patients with concomitant major cardio-respiratory disorders. (5) Patients judged to be incapable of using the PCA device (6) Patients who refuse to participate in the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the amount of morphine used during the first 48 hurs after surgery | 48 hours | No | |
Secondary | Comparing pain scores during the first 48 hours after surgery | 48 hours | No | |
Secondary | Comparing time to first rescue analgesia | 48 hours | Yes | |
Secondary | Comparing rescue analgesia used in the Post Anesthetic Care Unit (PACU) | 48 hours | Yes | |
Secondary | Comparing incidence of side effects of opioids such as respiratory depression, itching, nausea, and vomiting, dysphoria | 48 hours | Yes | |
Secondary | Comparing time to achieving discharge readiness in PACU | 48 hours | No | |
Secondary | Comparing time to achieving discharge rediness from the hospital | 48 hours | No | |
Secondary | comparing patient and parental satisfaction with pain management | 48 hours | No |
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