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Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.
This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Group | Experimental | Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. |
|
| Local Infiltration Group | Active Comparator | Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP block | Procedure | TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU. | Admission into PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaveh Aslani, MD | Beaumont Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
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This single-center, prospective, single blind, randomized study enrolled subjects who were scheduled for elective hydrocelectomy and/or hernia repair at Beaumont Hospital-Royal Oak. The first procedure was on 3/16/2012 and the last one was on 11/12/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAP Group | Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. |
| FG001 | Local Infiltration Group | Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data not included for patients removed from study by physician
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP Group | Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. |
| BG001 | Local Infiltration Group |
| 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 | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU. | Posted | Median | Inter-Quartile Range | units on a scale | Admission into PACU |
|
Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
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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 Group | Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | General disorders | Systematic Assessment |
Of the 47 treated patients, the local infiltration was administered by 8 different surgeons while the TAP block was administered by 2 different anesthesiologists.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaveh Aslani, MD | Beaumont Health | 248-898-81905 | kaslani@beaumont.org |
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| ID | Term |
|---|---|
| D006848 | Testicular Hydrocele |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Local Infiltration | Procedure | Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. |
|
Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Local Infiltration Group | Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 9 |
| 23 |
| EG001 | Local Infiltration Group | Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon. | 0 | 24 | 0 | 24 | 7 | 24 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal swelling | Gastrointestinal disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Incisional pain | Surgical and medical procedures | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| skin inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |