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The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block | Active Comparator | 20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance. |
|
| No Block | No Intervention | Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Block | Drug | Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 | 40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery). | Postop Day #1 or Day #2 |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Use | narcotic use in mg of Morphine will be recorded | Postop Day #0 and Day #1 |
| Visual Analog Scale (VAS) for Pain | visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah M Kane, MD | MetroHealth Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22840413 | Derived | Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tap Block | Patients undergoing Total Laparoscopic Hysterectomy were randomized with the Tap Block |
| FG001 | No Block | Patients undergoing Total Laparoscopic Hysterectomy were randomized without Tap Block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tap Block | Patients randomized to either Tap Block or No Tap Block |
| BG001 | No Block | Patients randomized to either Tap Block or No Tap Block |
| 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 | Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 | 40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery). | Posted | Median | Full Range | units on a scale | Postop Day #1 or Day #2 |
|
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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 | TAP Block | Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Pollard | MetroHealth Medical Center | 216-778-4444 | rpollard@metrohealth.org |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| 2 and 24 hours post operative |
| Intraoperative Time | The total time in the operating room will be recorded to see if there is a difference between groups. | the total intraoperative time in minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection. |
|
|
| Secondary | Narcotic Use | narcotic use in mg of Morphine will be recorded | Posted | Median | Full Range | mg of morphine | Postop Day #0 and Day #1 |
|
|
|
| Secondary | Visual Analog Scale (VAS) for Pain | visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.) | Posted | Median | Full Range | units on a scale | 2 and 24 hours post operative |
|
|
|
| Secondary | Intraoperative Time | The total time in the operating room will be recorded to see if there is a difference between groups. | Posted | Median | 95% Confidence Interval | Minutes | the total intraoperative time in minutes |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | No Block | Patients undergoing Total Laparoscopic Hysterectomy were randomized to either the Tap Block or Nothing | 0 | 28 | 0 | 28 | 0 | 28 |
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| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |