|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
The Baruch Padeh Medical Center, Poriya |
|---|---|
| Information provided by: | The Baruch Padeh Medical Center, Poriya |
| ClinicalTrials.gov Identifier: | NCT00914498 |
Purpose
This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.
| Condition | Intervention |
|---|---|
|
Pain Relief |
Drug: Local, pre-incisional injection of 20 ml 1% xylocaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section |
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Xylocaine: Experimental
Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site
|
Drug: Local, pre-incisional injection of 20 ml 1% xylocaine
Local, pre-incisional injection of 20 ml 1% xylocaine
|
|
Controls: Placebo Comparator
Participants will receive injection of 0.9% NaCl 20 ml to the incision site
|
Drug: Local, pre-incisional injection of 20 ml 1% xylocaine
Local, pre-incisional injection of 20 ml 1% xylocaine
|
Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain. Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section. The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits.
Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).
Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Izhar Ben-Shlomo, MD | 972-50-6268024 | izharbs@netvision.net.il |
| Contact: Aviva Peleg, MSc | 972-50-6267521 | apeleg@poria.health.gov.il |
| Israel | |
| Department of Obstetrics & Gynecology, Baruch Padeh Medical Center | Recruiting |
| Poriya, Israel | |
| Contact: Izhar Ben-Shlomo, MD 972-50-6268024 izharbs@netvision.net.il | |
| Contact: Aviva Peleg, MSc 972-50-6267521 apeleg@poria.health.gov.il | |
| Principal Investigator: Izhar Ben-Shlomo, MD | |
| Sub-Investigator: Nimrod Weitzman, MD | |
| Sub-Investigator: Dmitri Chuyun, MD | |
| Sub-Investigator: Moshe Ben-Ami, MD, Prof. | |
| Principal Investigator: | Izhar Ben-Shlomo, MD | Department of Obstetrics & Gynecology, Baruch Padeh Medical Center |
More Information
| Responsible Party: | The Baruch Padeh Medical Center ( Izhar Ben-Shlomo, MD, Senior Obstetrician & Gynecologist ) |
| Study ID Numbers: | Xylocaine CS Scar.CTIL |
| Study First Received: | June 4, 2009 |
| Last Updated: | August 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00914498 History of Changes |
| Health Authority: | Israel: Ministry of Health |
|
Xylocaine Casarean section Post operative pain Scar quality |
|
Signs and Symptoms Postoperative Complications Lidocaine Central Nervous System Depressants Anesthetics Pain |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Anesthetics, Local Pain, Postoperative Cicatrix |
|
Physiological Effects of Drugs Lidocaine Anesthetics Central Nervous System Depressants Pain Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Signs and Symptoms |
Pathologic Processes Postoperative Complications Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative |
