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| ID | Type | Description | Link |
|---|---|---|---|
| No NIH funding | Other Identifier | 11.07.23 |
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We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group.
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic assisted TAP block | Active Comparator | Laparoscopic assisted TAP block will be done by surgeon intra-operatively |
|
| no TAP block | No Intervention | no TAP block would be done |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP block with liposomal bupivacaine and bupivacaine | Drug | injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves |
| Measure | Description | Time Frame |
|---|---|---|
| pain scores at 24 hours in LA-TAP and NO TAP block groups | numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours. | 24 hour post op |
| Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively | MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time. | 24 hour post op |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups | numeric pain score (NPS) | 48 -72 hour post operative |
| amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farinaz Seifi, MD, FACOG | Yale University Obstetrics, Gynecology & Reproductive Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06492 | United States |
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morphine equivalent dose of narcotic use |
| 48 -72 hours post operative |
| Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op | nausea and vomiting, yes or no . | first 72 hours post operative |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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