Cesarean Delivery and Post-operative Pain Management With Local Anesthesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00298571|
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : June 15, 2012
|First Submitted Date ICMJE||February 28, 2006|
|First Posted Date ICMJE||March 2, 2006|
|Last Update Posted Date||June 15, 2012|
|Study Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00298571 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||improved hospital stay satisfaction|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Cesarean Delivery and Post-operative Pain Management With Local Anesthesia|
|Official Title ICMJE||Not Provided|
|Brief Summary||The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.|
Title: Cesarean Delivery and Postoperative Pain Management with Local Anesthesia
Investigators: Aaron Deutsch, MD, Principal Investigator Shelly Holmstrom, MD
Pain control has become a more prominent clinical issue. Typically, a patient undergoing a Cesarean delivery is administered spinal anesthesia just prior to the surgery.
Postoperative pain is managed with intravenous (IV) narcotics using a patient controlled anesthesia (PCA) pump device. Once the patient can tolerate oral medications, the PCA pump is discontinued and the patient uses oral narcotic medications for pain control.
Research has shown that injecting a local anesthetic in the subcutaneous tissue along the incision can reduce postoperative pain. The objective of this study is randomly assign patients to receive a local anesthetic or normal saline in the tissues surrounding the incision and to study the amount of pain experienced postoperatively in these groups of patients. Our hypothesis is that the patients receiving the local anesthesia along their incision will have significantly less pain postoperatively and use less narcotic medications.
Primary: To decrease postoperative pain in women undergoing Cesarean delivery Secondary: To decrease narcotic use, potentially decrease hospital length of stay, and increase patient satisfaction
Background, Study Rationale and Significance:
Local anesthesia injected at the incision site fro reduced postoperative pain has been studied in other abdominal surgeries. The research has demonstrated the effectiveness of this technique for reduced postoperative pain. One journal article describes a technique similar to the proposed research project1. However, this article did not show any significant difference in the postoperative pain following bupivacaine or normal saline injection of the skin. The authors' conclusion for this lack of significance was due to their facility's high quality analgesia via supplemental subarachnoid morphine.
Numerous other authors have demonstrated the effectiveness of using local anesthesia at incision sites for reducing pain postoperatively2-4. The proposed research project has the potential to decrease pain postoperatively, decrease hospital length of stay and increase patient satisfaction for one of the most common surgeries in the United States of America.
Patients currently undergoing a repeat Cesarean delivery with a history of a previous Cesarean delivery through a Pfannenstiel skin incision will be eligible to enroll in this study. All ages and races will be eligible. Exclusion criteria include patients with a primary Cesarean delivery, prior vertical skin incision or an allergy to bupivacaine. The projected sample size required for this study is 100 (50 patients in each arm).
This study is a randomized double blind placebo controlled trial. Patients will be randomized to either the bupivacaine or placebo (normal saline) group. An opaque envelope will contain a slip of paper indicating which fluid is to be injected. The anesthesiologist will open the envelope during the surgery and prepare 30 ml of the study drug. The patients will have their incision site injected with either the bupivacaine or normal saline at the completion of the surgery. The patients will be asked to assess their level of pain following the surgery on postoperative days 0, 1, 2 and 3 using a visual analog scale (VAS).
The hypothesis is that the patients receiving the bupivacaine injection will experience significantly less postoperative pain and use significantly less IV and oral narcotic medications.
Human Subject Issues
Informed Consent Informed consent will be obtained at the time of consent for cesarian delivery. The resident obtaining consent will also obtain the research consent. This will consist of explaining that the patient may receive either a local anesthetic or placebo to help assess better post-op pain control. Possible benefits will be explained along with minimal risks- no more than normal for a cesarian delivery.
The consent process will be available in Spanish and English when applicable.
Data Forms and Questionaire (see attached)
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Pain, Postoperative|
|Intervention ICMJE||Drug: .5% bupivacaine with epinephrine|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00298571|
|Other Study ID Numbers ICMJE||1212|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||University of South Florida|
|Study Sponsor ICMJE||University of South Florida|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of South Florida|
|Verification Date||February 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP