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| Sponsors and Collaborators: |
The Baruch Padeh Medical Center, Poriya Ministry of Health, Israel |
|---|---|
| Information provided by: | The Baruch Padeh Medical Center, Poriya |
| ClinicalTrials.gov Identifier: | NCT00728559 |
Purpose
In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy
| Condition | Intervention |
|---|---|
|
Pain |
Drug: bupivacain 0.5% |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
preemptive trocar site analgesia
|
Drug: bupivacain 0.5%
trocar site injection
|
|
2: Experimental
trocar site pre skin closure analgesia
|
Drug: bupivacain 0.5%
trocar site injection
|
|
3: No Intervention
control
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Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ilan atlas, md | 011972506267421 | ilanatlas@yahoo.com |
| Contact: samer tannus, md | 01197249540410 | stannus@bezeqint.net |
| Israel, Lower Galilee | |
| Poria Gov Hospital | |
| Tiberias, Lower Galilee, Israel, 15208 | |
| Study Chair: | Ilan Atlas, MD | Ministry of Health, Israel |
More Information
| Responsible Party: | Poria Medical Center ( Ilan Atlas, MD Gynecologic Oncology Director ) |
| Study ID Numbers: | lapmar1 |
| Study First Received: | August 1, 2008 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00728559 |
| Health Authority: | Israel: Ministry of Health |
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laparoscopy preemptive postoperative |
pain trocar site |
|
Bupivacaine Pain |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
