Hydrocele, Inguinal Hernia
Conditions
Brief summary
Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.
Detailed description
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.
Interventions
PROCEDURETAP block
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
PROCEDURELocal Infiltration
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
Sponsors
Kaveh Aslani, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Children 2-8 years of age * Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak * American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)
Exclusion criteria
* History of allergy to study medications * Enrollment in concurrent research study * Pregnant patients\* * Students/trainees/staff\* * Mentally disabled/cognitively impaired\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | Admission into PACU | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | TAP Group | Local Infiltration Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 24 Participants | 47 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 9 / 23 | 7 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
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.
Time frame: Admission into PACU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP Group | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | 0 units on a scale |
| Local Infiltration Group | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | 0 units on a scale |