Umbilical Hernia
Conditions
Keywords
Rectus Sheath, Local infiltration, Pain Control
Brief summary
Umbilical hernia repair is a common painful outpatient procedure performed in children. Often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. The rectus sheath block can be performed in these patients to decrease their post operative pain.
Detailed description
Umbilical hernia repair, a common Day Surgery procedure in children, is associated with considerable postoperative discomfort. The patient has to meet certain discharge criteria such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from the day surgery unit. Currently, both rectus sheath block and local infiltration of the surgical site are used for providing post-operative analgesia for umbilical hernia repair surgery. The local infiltration can only be done at the end of the surgical procedure as it could alter the planes of the surgical field if performed preoperatively. We believe that the analgesia provided prior to the surgical incision will decrease the amount of intraoperative and postoperative opioids used and the subsequent side effects of these medications (5,6). The rectus sheath block, a regional anesthetic technique, offers possible improved pain management following umbilical hernia repair in a recent observational study (1-3,7). We will perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and surgical infiltration in providing postoperative analgesia.
Interventions
DRUGBupivacaine
Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.
Sponsors
Children's Anesthesiology Associates, Ltd.
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects ages \> 5 to \< 18 years. 2. American Society of Anesthesiology (ASA)physical status 1 or 2. 3. Patients who undergo an umbilical hernia repair at CHOP.
Exclusion criteria
1. Parents/patients refusal to the placement of a rectus sheath nerve block. 2. Subjects with allergy to bupivacaine. 3. Patients who are developmentally delayed which precludes their participation in pain scale reporting. 4. Parents who do not comprehend English sufficiently well to read the consent and ask questions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia. | immediate to 24 hour post-operatively | total postoperative opioid and any additional analgesic medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management. | immediate to 24 hours post-operatively | difference in time to rescue analgesic and the differences in side effects for the two groups. |
Countries
United States
Participant flow
Recruitment details
52 patients completed the study, having hernia repair as a day-surgery procedure.
Pre-assignment details
We screened 120 subjects and excluded 66, 35 patients did not fit the criteria and 31 patients declined to participate. 54 subjects were randomized to receive either a rectus sheath block or local anesthetic infiltration. Two randomized subjects did not get the intervention. 52 subjects did get the intervention - 26 in each arm.
Participants by arm
| Arm | Count |
|---|---|
| Rectus Sheath Block 1\) One group will receive the rectus sheath block prior to Umbilical hernia repair. | 26 |
| Local Infiltration 2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not given intervention | 1 | 1 |
Baseline characteristics
| Characteristic | Local Infiltration | Rectus Sheath Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 26 Participants | 26 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.9 years STANDARD_DEVIATION 0.88 | 7.7 years STANDARD_DEVIATION 0.88 | 7.8 years STANDARD_DEVIATION 0.88 |
| Region of Enrollment United States | 26 participants | 26 participants | 52 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 26 | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.
total postoperative opioid and any additional analgesic medications.
Time frame: immediate to 24 hour post-operatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rectus Sheath Block | The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia. | 0.07 mg kg-1 |
| Local Infiltration | The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia. | 0.13 mg kg-1 |
Comparison: Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.p-value: 0.008Wilcoxon (Mann-Whitney)
Secondary
The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.
difference in time to rescue analgesic and the differences in side effects for the two groups.
Time frame: immediate to 24 hours post-operatively
Population: Time to first rescue dose of opioid medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectus Sheath Block | The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management. | 49.70 minutes | Standard Deviation 36.94 |
| Local Infiltration | The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management. | 32.35 minutes | Standard Deviation 29.39 |