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| ID | Type | Description | Link |
|---|---|---|---|
| HS# 11-00013 |
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The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.
Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10).
For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.
Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | Subjects receive paracervical block with bupivacaine-epinephrine |
|
| Saline | Placebo Comparator | Subjects receive paracervical injection of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management | Four hours after conclusion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. | 1and 2 hour postoperatively |
| Postoperative Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Ascher-Walsh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18830553 | Background | Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2. |
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Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision. |
| FG001 | Saline | Subjects injected paracervically with 10 ml of normal saline prior to surgical incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision. |
| BG001 | Saline | Subjects injected paracervically with 10 ml of normal saline prior to surgical incision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management | Posted | Count of Participants | Participants | Four hours after conclusion of surgery |
|
Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, & radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
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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 | Bupivacaine | Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stress Incontinence | Renal and urinary disorders | Stress incontinence requiring a midurethral sling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel L. Barr Grzesh | Icahn School of Medicine at Mount Sinai | 212-241-2995 | rachel.barr@mssm.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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug | Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision. |
|
|
Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level. |
| 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative |
| Postoperative Day Pain Medication Use | Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively. | Postoperative days 0-10 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Parity | Count of Participants | Participants |
|
| Surgical Indication | Count of Participants | Participants |
|
| Uterine Size | Mean | Standard Deviation | weeks |
|
| Preoperative Hematocrit | Mean | Standard Deviation | % of cells |
|
| Admission Planned | planned overnight admission for non-medical reasons | Number | admissions |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Postoperative Pain Score | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. | This doesn't include hospitalization for reasons other than pain management. | Posted | Mean | Standard Deviation | units on a scale | 1and 2 hour postoperatively |
|
|
|
| Secondary | Postoperative Pain Score | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level. | Only those subjects with pain analyzed | Posted | Mean | Standard Deviation | units on a scale | 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative |
|
|
|
| Secondary | Postoperative Day Pain Medication Use | Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively. | missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm | Posted | Number | participants | Postoperative days 0-10 |
|
|
|
| 0 |
| 68 |
| 1 |
| 68 |
| 17 |
| 68 |
| EG001 | Saline | Subjects injected paracervically with 10 ml of normal saline prior to surgical incision. | 0 | 64 | 0 | 64 | 16 | 64 |
| Incisional Infection | Injury, poisoning and procedural complications |
|
| Urinary Retention | Renal and urinary disorders |
|
| Small Bowel Mesenteric Hematoma | Injury, poisoning and procedural complications | a small bowel mesenteric hematoma caused by Veress needle injury that did not require surgical management |
|
| Skin laceration | Injury, poisoning and procedural complications | skin laceration from the morcellator |
|
| Cervical infection | Reproductive system and breast disorders |
|
| Retropubic hematoma | Injury, poisoning and procedural complications |
|
| Bladder performation | Injury, poisoning and procedural complications | bladder perforation during a concomitant retropubic midurethral sling procedure |
|
| Seizure | General disorders | unknown etiology |
|
| Emergency Room Visit | General disorders | ER visit for nausea, vomiting, and headache |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 2 hours postoperative |
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| 4 hours postoperative |
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| Day 1 postoperative |
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| Day 2 postoperative |
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| Postoperative Day 2 |
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| Postoperative Day 3 |
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| Postoperative Day 4 |
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| Postoperative Day 5 |
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| Postoperative Day 6 |
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| Postoperative Day 7 |
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| Postoperative Day 8 |
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| Postoperative Day 9 |
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| Postoperative Day 10 |
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