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The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block.
Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.
Protocol:
After receiving approval for the study, the researchers will conduct a prospective single institution randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores after surgery. Other endpoints include whether there are differences in pain medication usage and complications.
Patients will be screened by research team members and attending surgeons. If the patient is interested, the researchers will consent the participants for the study after understanding the study details, procedures, and expectations. The researchers will then consent using IRB approved study consent forms and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to standard procedures. The study will assess if a TAP block impacts pain scores. Patients will be randomized to receive the intervention or placebo. Sequentially numbered sealed opaque envelopes with group allocation inside will alert the anesthesiologist & surgeon to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).
Inguinal hernia repair will be performed in standard fashion that each individual surgeon is familiar with. No additional tests or blood work outside the standard of care for IHR will be performed for research purposes. In addition, some patients will be given TAP blocks before surgery to help in pain management. Patients will be discharged with a worksheet on which the participants are to record analgesic use and pain scores on postoperative days one, two, three and four. The participants are expected to bring the completed log to their two-week follow up visit with their surgeon. Patients may also expect to receive a phone call from a member of the surgical team to remind them to record these metrics.
The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh<100 kg, the patients will receive a total of 50 ml (25 ml on each side of the abdominal wall). If patients weigh>100 kg, the patients will receive a total of 60 ml (30ml on each side of the abdominal wall). The TAP plane is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.
Patients will be discharged with a worksheet /survey on which the patients are to record analgesic use and pain scores on postoperative days one, two, three and four. The patients are expected to bring the completed log to their two-week follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal Saline: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. |
|
| Experimental | Experimental | 0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% Bupivacaine | Drug | received during TAP block |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at Rest | On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain. | on post-op days 1, 2, 3, and 4 |
| Pain Score at Rest | On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain. | All post-op (average 4 days) |
| Pain Score at Movement | On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain. | on post-op days 1, 2, 3, and 4 |
| Pain Score at Movement | On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain. | All post-op (average 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Opioid Pills | Patients recorded the number of opioid pills taken. | on post-op days 1, 2, 3, and 4 |
| Number of Opioid Pills | Patients recorded the number of opioid pills taken. |
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Inclusion Criteria:
- Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celia M Divino, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
Individual participant data will not be shared. Data will be published in aggregate form without any PHI or references to the patient so as to keep identifying information secure.
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Recruitment performed in outpatient office from 12/9/2019 to 07/23/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Normal Saline: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
| FG001 | Experimental | 0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Normal Saline: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
| 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 | Pain Score at Rest | On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | on post-op days 1, 2, 3, and 4 |
|
up to 2 weeks post-surgery
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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 | Normal Saline: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
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Demographic information, like race and ethnicity was not obtained.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celia Divino | Icahn School of Medicine at Mount Sinai | (212) 241-3348 | celia.divino@mountsinai.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 | Aug 10, 2022 | Jul 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2023 | Jan 10, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
placebo equivalent |
|
| TAP block | Procedure | The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
|
| All post-op (average 4 days) |
| Number of Non-opioid Pain Medication | Patients recorded the number of non-opioid pills taken for pain control. | on post-op days 1, 2, 3, and 4 |
| Number of Non-opioid Pain Medication | Patients recorded the number of non-opioid pills taken for pain control. | All post-op (average 4 days) |
| Number of Intraoperative Complications | Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures. | up to 2 weeks post-surgery |
| Number of Participants With Contents in the Hernia | Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder. | during procedure |
| Number of Surgical Tacks Used Per Repair | Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain. | during procedure |
| Procedure Time | Procedure duration in minutes. | during procedure |
| Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure. | during procedure |
| Number of Patients Per Anesthesiologist | The number of patients handled per anesthesiologist. | during procedure |
| BG001 | Experimental | 0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Experimental |
0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). |
|
|
| Primary | Pain Score at Rest | On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | All post-op (average 4 days) |
|
|
|
| Primary | Pain Score at Movement | On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | on post-op days 1, 2, 3, and 4 |
|
|
|
| Primary | Pain Score at Movement | On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | All post-op (average 4 days) |
|
|
|
| Secondary | Number of Opioid Pills | Patients recorded the number of opioid pills taken. | Posted | Mean | Standard Deviation | number of pills | on post-op days 1, 2, 3, and 4 |
|
|
|
| Secondary | Number of Opioid Pills | Patients recorded the number of opioid pills taken. | Posted | Mean | Standard Deviation | number of pills | All post-op (average 4 days) |
|
|
|
| Secondary | Number of Non-opioid Pain Medication | Patients recorded the number of non-opioid pills taken for pain control. | Posted | Mean | Standard Deviation | number of pills | on post-op days 1, 2, 3, and 4 |
|
|
|
| Secondary | Number of Non-opioid Pain Medication | Patients recorded the number of non-opioid pills taken for pain control. | Posted | Mean | Standard Deviation | number of pills | All post-op (average 4 days) |
|
|
|
| Secondary | Number of Intraoperative Complications | Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures. | Posted | Number | number of complications | up to 2 weeks post-surgery |
|
|
|
| Secondary | Number of Participants With Contents in the Hernia | Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder. | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Secondary | Number of Surgical Tacks Used Per Repair | Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain. | There were a number of participants that were missing this data. This is due to human error for not inputting the information. | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Secondary | Procedure Time | Procedure duration in minutes. | Posted | Mean | Standard Deviation | Minutes | during procedure |
|
|
|
| Secondary | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure. | A participant was missing this data. This is due to human error for not inputting the information. | Posted | Count of Participants | Participants | during procedure |
|
|
|
| Secondary | Number of Patients Per Anesthesiologist | The number of patients handled per anesthesiologist. | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Experimental | 0.25% bupivacaine: For patients weighing <100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.). | 0 | 46 | 0 | 46 | 0 | 46 |
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| D000588 |
| Amines |
| post-op day 3 |
|
| post-op day 4 |
|
| post-op day 3 |
|
| post-op day 4 |
|
| post-op day 3 |
|
| post-op day 4 |
|
| Early Recurrence |
|
| Hematoma |
|
| Induration |
|
| Lipoma |
|
| Omentum |
|
| Bladder |
|
| 6 |
|
| Data not collected |
|
| Data not collected |
|
| Anesthesiologist 3 |
|
| Anesthesiologist 4 |
|