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To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anesthetic intervention | Experimental | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. |
|
| Saline intervention | Placebo Comparator | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Bupivicaine | Drug | Local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Score Assessment (VAS) | Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain) | Post-operative period |
| Visual Analog Scale Pain Score Assessment (VAS) | Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable) | Pain scale 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Pain Medication Used in Oral Morphine Equivalents | Total mg of opiate after surgery | 4 hours after surgery |
| Duration of Narcotic Used to Control Pain | Number of days post-operatively narcotic is used |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36266481 | Derived | Rade M, Jayaram A, Birkett R, Ford H, Birkett D, Nepomnayshy D. A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair. Surg Endosc. 2023 Mar;37(3):1970-1975. doi: 10.1007/s00464-022-09697-7. Epub 2022 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anesthetic Intervention | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic |
| FG001 | Saline Intervention | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anesthetic Intervention | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic |
| BG001 | Saline Intervention |
| 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 | Visual Analog Scale Pain Score Assessment (VAS) | Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | Post-operative period |
|
2 weeks
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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 | Anesthetic Intervention | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dmitry nepomnayshy MD | Lahey Clinic | 781 744 8576 | dmitry.nepomnayshy@lahey.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2013 | Oct 7, 2020 | Prot_SAP_000.pdf |
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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 |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 4 weeks post-op |
After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Visual Analog Scale Pain Score Assessment (VAS) | Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | Pain scale 3 days after surgery |
|
|
|
| Secondary | Amount of Pain Medication Used in Oral Morphine Equivalents | Total mg of opiate after surgery | one patient's data is missing | Posted | Mean | Standard Deviation | oral morphine equivalents | 4 hours after surgery |
|
|
|
| Secondary | Duration of Narcotic Used to Control Pain | Number of days post-operatively narcotic is used | Data were not collected for any patients. | Posted | 4 weeks post-op |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Saline Intervention | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |