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Investigator no longer recruiting subjects.
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The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marcaine administered pre-incision. | Active Comparator | Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. |
|
| Marcaine administered post-incision | Active Comparator | Marcaine 0.25% administered post-incision, total amount 5cc per incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine- 0.25% | Drug | Marcaine 0.25% administered pre-incision. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain. | Post surgery day 0, post surgery day 1, post surgery day 2 |
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Inclusion Criteria:
• Ages 18-50
Exclusion Criteria:
• Age or BMI out of range
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Schattman, MD | Weill Medical College of Cornell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Singer T, Huang JY, Schattman GL, Joseph M, Stubbs RE, Rosenwaks Z. RCT- Comparing Bupivicaine Adminstration in Laparoscopic Gynecologic Surgery Using Either a Pre-Incision or Post-Closure Injection. Journal of Minimally Invasive Gynecology 19 (6): S46, 2012. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication Pre Incision Left Med Post Incision Right | Subjects acted as their own control with the left side being injected with the medication pre incision and the right side being injected with medication post incision. |
| FG001 | Medication Pre Incision Right Med Post Incision Left | Subjects acted as their own control with right side being injected with the medication pre incision and left side being injected with the medication post incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication Pre Incision Left Med Post Incision Right | Participants acted as their own control with left side being injected with medication pre incision and right side being injected with medication post incision. |
| BG001 | Medication Pre Incision Right Med Post Incision Left |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wong-Baker Faces Pain Rating Scale | Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain. | Posted | Mean | Standard Deviation | units on a scale | Post surgery day 0, post surgery day 1, post surgery day 2 |
|
Adverse event data was monitored up to two weeks post op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Marcaine Administered Pre-incision. | Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. Marcaine- 0.25%: Marcaine 0.25% administered pre-incision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glenn Schattman, Associate Professor | Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine. | 646-962-3836 | glschatt@med.cornell.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
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| Marcaine 0.25%. |
| Drug |
Marcaine 0.25% administered post-incision. |
|
Participants acted as their own control with right side being injected with medication pre incision and left side being injected with medication post incision. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Post-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc post incision.
Marcaine- 0.25%: Marcaine 0.25% administered post-incision.
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Marcaine Administered Post-incision | Marcaine 0.25% administered post-incision, total amount 5cc per incision. Marcaine 0.25%.: Marcaine 0.25% administered post-incision. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |