Pediatric Postoperative PainNCT01015053
Postoperative Pain After Pediatric Umbilical Hernia Repair
A study testing bilateral ultrasound-guided rectus sheath block and Wound infiltration in people with Pediatric Postoperative Pain, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pediatric Postoperative Pain
- What is being tested?
- bilateral ultrasound-guided rectus sheath block and Wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any patient who is 3 to 12 years of age
- Any patient undergoing outpatient umbilical hernia repair
- Any patient capable of expressing pain using the Faces Pain Rating Scale
- Patient has provided assent (if age 10 or older)
- Parents/guardians have provided informed consent
Who cannot join
- Any patient classified as ASA III, IV, or V by the American Society of Anesthesiologists
- Any patient with a history of Complex Regional Pain Syndrome
- Any patient with a history of chronic analgesic use
- Any patient who has used an analgesic including opioids, acetaminophen, and/or NSAID's within 24 hours prior to surgery
- Wards of the state
- Any patient with an incarcerated umbilical hernia requiring emergent surgery
Show all 13Show fewer
- Any patient who does not speak English or Spanish
- Any patient whose primary caregiver does not speak English or Spanish
- Any patient who cannot express pain using the Faces Pain Rating Scale due to a disability
- Any patient whose primary caregiver is unable to comply with home instructions due to a disability
- Any patient less than 3 years of age or greater than 12 years of age
- Any patient with renal insufficiency
- Any patient with a bleeding disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Children's Hospital Boston at Waltham
Waltham, Massachusetts, 02453
About this study
Official title: Postoperative Pain After Pediatric Umbilical Hernia Repair: a Randomized Clinical Trial of Ultrasound-guided Bilateral Rectus Sheath Blocks Versus Local Anesthetic Infiltration
The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair.
Read the detailed description
Recent studies on adult patients' perceptions of their hospital care have shown that improvements are needed in pain management (Jha, Orav, Zheng, and Epstein). The use of regional anesthetic techniques to block specific peripheral nerves in adult patients has increased in recent decades as an alternative to general anesthesia or to decrease opioid use during and after surgery. Decreased postoperative complications have been observed, with fewer ambulatory patients requiring prolonged recovery room stays and/or costly unplanned hospital admissions (Chan, Peng, Kaszas, Middleton, Muni, Anastakis, and Graham).
Regional anesthetic techniques have not been widely performed in pediatric patients because of the challenge in requiring children to report paresthesias during needle placements. However, pediatric anesthesiologists have recently begun to use ultrasound to identify anatomy, and to guide needle insertion and local anesthetic infiltration, thereby enabling peripheral nerve blocks to be performed safely in children under general anesthesia. Several studies have illustrated that umbilical nerve blocks (Jose Maria, Götzens, and Mabrok) and rectus sheath blocks (Willschke, Bosenberg, Marhofer, Johnston, Kettner, Wanzel, and Kapral) can be used safely and effectively with ultrasound guidance in pediatric outpatient surgery. To date, few studies have explored whether ultrasound-guided regional blocks of the abdomen in children have the desired outcome of reducing postoperative pain and/or decreasing opioid use.
The use of ultrasound to guide the deposition of local anesthetic in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen may decrease postoperative pain, opioid and non-opioid analgesic consumption, as well as minimize opioid-related complications. Currently, at Children's Hospital Boston, the most common regimen for pain control after umbilical hernia repair performed under general anesthesia (i.e. standard of care) has been surgeon-administered nonspecific local anesthetic infiltration in the wound at the conclusion of surgery, followed by opioids in the Post-Anesthesia Care Unit and an oral opioid/acetaminophen combination post-discharge. In sporadic cases over the past year, several pediatric surgeons have collaborated with anesthesiologists from the pain service to allow ultrasound-guided bilateral rectus sheath blocks to be performed in patients undergoing umbilical hernia repair, usually prior to the surgical repair, and often concomitantly with surgeon-administered local anesthetic infiltration in the wound. Because of the anecdotal nature of these practices, specific conclusions regarding improvements in post-operative pain or decreased need for post-operative opioid use cannot be drawn. However, anecdotal reports from parents at the time of outpatient post-operative follow-up visits have been encouraging regarding perceived success in achieving adequate post-operative pain control in patients receiving the regional block.
We propose an interdisciplinary, prospective, randomized, single-blinded clinical trial of the use of ultrasound-guided bilateral rectus sheath blocks versus local anesthetic infiltration in a pediatric population of patients undergoing ambulatory umbilical hernia repair at Children's Hospital Boston and Children's Hospital Boston at Waltham.
- Conditions
- Pediatric Postoperative Pain
- Being tested
- bilateral ultrasound-guided rectus sheath block, Wound infiltration
- Keywords
- postoperative pain, pediatric, umbilical hernia, ropivacaine, rectus sheath block, regional block, ultrasound-guided regional block, local infiltration, ambulatory surgery
- Medical subject headings
- Pain, Postoperative, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral ultrasound-guided rectus sheath blockProcedure or surgery
Also called ropivacaine
Ultrasound is used to guide the deposition of Ropivacaine 0.2% 1cc/kg in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen.
Wound infiltrationProcedure or surgery
Also called ropivacaine
Ropivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Regional block | Experimental | An ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm. Receives: Procedure: bilateral ultrasound-guided rectus sheath block |
| Wound infiltration | Active comparator | Local wound infiltration will be performed by the surgeon in the "wound infiltration" arm. Receives: Procedure: Wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: from emergence to 24 hrs post-discharge
Secondary outcomes (1)
postoperative use of opioids and non-opioids
Measured: from emergence to 24 hrs post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric Postoperative PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Catalyst Pilot Grant, Harvard University
- Responsible party
- Principal investigator, Catherine Chen, Boston Children's Hospital
- Investigators
- Catherine Chen, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015053
- Sponsor's protocol ID
- 09-08-0398
- Status last verified
- Sep 2017
- First submitted
- 12 Nov 2009
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008 Oct 30;359(18):1921-31. doi: 10.1056/NEJMsa0804116.
PubMed 18971493Chan VW, Peng PW, Kaszas Z, Middleton WJ, Muni R, Anastakis DG, Graham BA. A comparative study of general anesthesia, intravenous regional anesthesia, and axillary block for outpatient hand surgery: clinical outcome and cost analysis. Anesth Analg. 2001 Nov;93(5):1181-4. doi: 10.1097/00000539-200111000-00025.
PubMed 11682392de Jose Maria B, Gotzens V, Mabrok M. Ultrasound-guided umbilical nerve block in children: a brief description of a new approach. Paediatr Anaesth. 2007 Jan;17(1):44-50. doi: 10.1111/j.1460-9592.2006.02025.x.
PubMed 17184431Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.
PubMed 16798774Dingeman RS, Barus LM, Chung HK, Clendenin DJ, Lee CS, Tracy S, Johnson VM, Dennett KV, Zurakowski D, Chen C. Ultrasonography-guided bilateral rectus sheath block vs local anesthetic infiltration after pediatric umbilical hernia repair: a prospective randomized clinical trial. JAMA Surg. 2013 Aug;148(8):707-13. doi: 10.1001/jamasurg.2013.1442.
PubMed 23760519
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Pediatric Umbilical Hernia Repair: a Randomized Clinical Trial of Ultrasound-guided Bilateral Rectus Sheath Blocks Versus Local Anesthetic Infiltration
- ClinicalTrials.gov ID
- NCT01015053
- Acronym / sponsor ID
- 09-08-0398
- Conditions
- Pediatric Postoperative Pain
- Keywords
- postoperative pain, pediatric, umbilical hernia, ropivacaine, rectus sheath block, regional block, ultrasound-guided regional block, local infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard Catalyst Pilot Grant, Harvard University
- Study start
- Nov 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair.
Detailed description
Recent studies on adult patients' perceptions of their hospital care have shown that improvements are needed in pain management (Jha, Orav, Zheng, and Epstein). The use of regional anesthetic techniques to block specific peripheral nerves in adult patients has increased in recent decades as an alternative to general anesthesia or to decrease opioid use during and after surgery. Decreased postoperative complications have been observed, with fewer ambulatory patients requiring prolonged recovery room stays and/or costly unplanned hospital admissions (Chan, Peng, Kaszas, Middleton, Muni, Anastakis, and Graham).
Regional anesthetic techniques have not been widely performed in pediatric patients because of the challenge in requiring children to report paresthesias during needle placements. However, pediatric anesthesiologists have recently begun to use ultrasound to identify anatomy, and to guide needle insertion and local anesthetic infiltration, thereby enabling peripheral nerve blocks to be performed safely in children under general anesthesia. Several studies have illustrated that umbilical nerve blocks (Jose Maria, Götzens, and Mabrok) and rectus sheath blocks (Willschke, Bosenberg, Marhofer, Johnston, Kettner, Wanzel, and Kapral) can be used safely and effectively with ultrasound guidance in pediatric outpatient surgery. To date, few studies have explored whether ultrasound-guided regional blocks of the abdomen in children have the desired outcome of reducing postoperative pain and/or decreasing opioid use.
The use of ultrasound to guide the deposition of local anesthetic in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen may decrease postoperative pain, opioid and non-opioid analgesic consumption, as well as minimize opioid-related complications. Currently, at Children's Hospital Boston, the most common regimen for pain control after umbilical hernia repair performed under general anesthesia (i.e. standard of care) has been surgeon-administered nonspecific local anesthetic infiltration in the wound at the conclusion of surgery, followed by opioids in the Post-Anesthesia Care Unit and an oral opioid/acetaminophen combination post-discharge. In sporadic cases over the past year, several pediatric surgeons have collaborated with anesthesiologists from the pain service to allow ultrasound-guided bilateral rectus sheath blocks to be performed in patients undergoing umbilical hernia repair, usually prior to the surgical repair, and often concomitantly with surgeon-administered local anesthetic infiltration in the wound. Because of the anecdotal nature of these practices, specific conclusions regarding improvements in post-operative pain or decreased need for post-operative opioid use cannot be drawn. However, anecdotal reports from parents at the time of outpatient post-operative follow-up visits have been encouraging regarding perceived success in achieving adequate post-operative pain control in patients receiving the regional block.
We propose an interdisciplinary, prospective, randomized, single-blinded clinical trial of the use of ultrasound-guided bilateral rectus sheath blocks versus local anesthetic infiltration in a pediatric population of patients undergoing ambulatory umbilical hernia repair at Children's Hospital Boston and Children's Hospital Boston at Waltham.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional block | Experimental | Procedure: bilateral ultrasound-guided rectus sheath blockAn ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm. |
| Wound infiltration | Active comparator | Procedure: Wound infiltrationLocal wound infiltration will be performed by the surgeon in the "wound infiltration" arm. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any patient who is 3 to 12 years of age
- Any patient undergoing outpatient umbilical hernia repair
- Any patient capable of expressing pain using the Faces Pain Rating Scale
- Patient has provided assent (if age 10 or older)
- Parents/guardians have provided informed consent
Key exclusion criteria (13 listed)
- Any patient classified as ASA III, IV, or V by the American Society of Anesthesiologists
- Any patient with a history of Complex Regional Pain Syndrome
- Any patient with a history of chronic analgesic use
- Any patient who has used an analgesic including opioids, acetaminophen, and/or NSAID's within 24 hours prior to surgery
- Wards of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral ultrasound-guided rectus sheath blockAlso: ropivacaineUltrasound is used to guide the deposition of Ropivacaine 0.2% 1cc/kg in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen. | Procedure or surgery | Regional block |
| Wound infiltrationAlso: ropivacaineRopivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon. | Procedure or surgery | Wound infiltration |
Primary outcome
postoperative pain
Time frame: from emergence to 24 hrs post-discharge
1 secondary outcome
postoperative use of opioids and non-opioids
Time frame: from emergence to 24 hrs post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Background: PubMed 18971493Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008 Oct 30;359(18):1921-31. doi: 10.1056/NEJMsa0804116.
- Background: PubMed 11682392Chan VW, Peng PW, Kaszas Z, Middleton WJ, Muni R, Anastakis DG, Graham BA. A comparative study of general anesthesia, intravenous regional anesthesia, and axillary block for outpatient hand surgery: clinical outcome and cost analysis. Anesth Analg. 2001 Nov;93(5):1181-4. doi: 10.1097/00000539-200111000-00025.
- Background: PubMed 17184431de Jose Maria B, Gotzens V, Mabrok M. Ultrasound-guided umbilical nerve block in children: a brief description of a new approach. Paediatr Anaesth. 2007 Jan;17(1):44-50. doi: 10.1111/j.1460-9592.2006.02025.x.
- Background: PubMed 16798774Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.
- Derived from this study: PubMed 23760519Dingeman RS, Barus LM, Chung HK, Clendenin DJ, Lee CS, Tracy S, Johnson VM, Dennett KV, Zurakowski D, Chen C. Ultrasonography-guided bilateral rectus sheath block vs local anesthetic infiltration after pediatric umbilical hernia repair: a prospective randomized clinical trial. JAMA Surg. 2013 Aug;148(8):707-13. doi: 10.1001/jamasurg.2013.1442.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Chen, MD, MPH principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral ultrasound-guided rectus sheath block and Wound infiltration in people with Pediatric Postoperative Pain, run by Boston Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: from emergence to 24 hrs post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015053, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.