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The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | (control group) will receive sterile normal saline in the block |
|
| Active comparator | Active Comparator | (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Bilateral TAP block using sterile normal saline. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery 40 Score | Quality of Recovery 40 Score at 24 hours postoperative. | 24 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Total Opioid Consumption. | 24 Hour total opioid consumption translated into IV morphine equivalents. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out criteria:
Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio DeOliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11179243 | Background | Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430. | |
| 6691724 | Background | Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020. |
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26 were assessed for eligibility. 7 were excluded ( 4 did not meet inclusion criteria and 3 refused to participate).
Subjects were enrolled consecutively from 03/2010 through 07/2012 in the pre operative area of the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | (control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline. |
| FG001 | Active Comparator | (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. |
| Drug |
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. |
|
| 9717428 | Background | Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506. |
| 8652329 | Background | Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available. |
| 3354874 | Background | Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82. |
| 10475322 | Background | Dhonneur G, Combes X, Leroux B, Duvaldestin P. Postoperative obstructive apnea. Anesth Analg. 1999 Sep;89(3):762-7. doi: 10.1097/00000539-199909000-00045. |
| 6751498 | Background | Chung F, Crago RR. Sleep apnoea syndrome and anaesthesia. Can Anaesth Soc J. 1982 Sep;29(5):439-45. doi: 10.1007/BF03009406. |
| 19700053 | Background | Passannante AN, Tielborg M. Anesthetic management of patients with obesity with and without sleep apnea. Clin Chest Med. 2009 Sep;30(3):569-79, x. doi: 10.1016/j.ccm.2009.05.009. |
| 10718794 | Background | Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x. |
| 10910857 | Background | Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032. |
| 11703235 | Background | Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | (control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline. |
| BG001 | Active Comparator | (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Quality of Recovery 40 Score | Quality of Recovery 40 Score at 24 hours postoperative. | Posted | Median | Inter-Quartile Range | units on scale 40 (low) - 200 (high) | 24 hours post operatively |
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| Secondary | 24 Hour Total Opioid Consumption. | 24 Hour total opioid consumption translated into IV morphine equivalents. | Posted | Median | Inter-Quartile Range | miligram IV morphine equivalents | 24 hours |
|
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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 | Placebo | (control group) will receive sterile normal saline in the block Placebo: Bilateral TAP block using sterile normal saline. | 0 | 9 | 3 | 9 | ||
| EG001 | Active Comparator | (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. | 0 | 10 | 1 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Nausea | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | Vomiting | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira MD,MS | Northwestern University | 312-472-3573 | g-jr@northwestern.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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|