Postoperative PainPhase 2NCT01662401
Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
A Phase 2 study testing Bupivacaine in people with Postoperative Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2010
- Phase
- Phase 2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children scheduled for laparoscopic appendectomy between the ages of 6 and 18
- Written informed consent from parent of guardian
Who cannot join
- Sensitivities to local anesthetics
- Significant renal, liver, or cardiac disease
- Appendectomy requiring an open procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Comparison of Peripheral Nerve Blocks to Local Anesthetic
After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most children will still require additional pain medications after surgery. The purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.
Read the detailed description
A study investigator who is not involved in the immediate care of the patient will use a computer generated randomized table as to whether a child undergoing laparoscopic appendectomy will receive local anesthetic infiltration to the laparoscopic port placement sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia. The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the minimum amount of local anesthetic needed for a successful block. This will be the dose for each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port sites by surgeons will also be limited to a total of 14 ml. If a subject does not have adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05 mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per surgeon preference. A blinded observer will observe the subject for pain in the PACU using a validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain medications will be noted by an observer in the PACU and followed for the first 24 hours postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral nerve blocks versus local anesthetic infiltration.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine
- Keywords
- children, laparoscopic appendectomy, iliohypogastric nerve block, rectus sheath nerve block, ilioinguinal nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.
BupivacaineDrug
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Block | Experimental | bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject Receives: Drug: Bupivacaine |
| local anesthetic infiltration | Experimental | local anesthetic infiltration will be administered after induction of general anesthesia Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laparoscopic appendectomy infiltration that reduces postoperative pain
Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
Measured: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startMay 2008
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662401
- Sponsor's protocol ID
- CMH IRB 2008-13399
- Status last verified
- Aug 2012
- First submitted
- 12 Jul 2012
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferguson S, Thomas V, Lewis I. The rectus sheath block in paediatric anaesthesia: new indications for an old technique? Paediatr Anaesth. 1996;6(6):463-6. doi: 10.1046/j.1460-9592.1996.d01-24.x.
PubMed 8936544Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. doi: 10.1213/01.ane.0000217196.34354.5a.
PubMed 16717308
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Comparison of Peripheral Nerve Blocks to Local Anesthetic
- ClinicalTrials.gov ID
- NCT01662401
- Acronym / sponsor ID
- CMH IRB 2008-13399
- Conditions
- Postoperative Pain
- Keywords
- children, laparoscopic appendectomy, iliohypogastric nerve block, rectus sheath nerve block, ilioinguinal nerve block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 10 Aug 2012 (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.
After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most children will still require additional pain medications after surgery. The purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.
Detailed description
A study investigator who is not involved in the immediate care of the patient will use a computer generated randomized table as to whether a child undergoing laparoscopic appendectomy will receive local anesthetic infiltration to the laparoscopic port placement sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia. The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the minimum amount of local anesthetic needed for a successful block. This will be the dose for each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port sites by surgeons will also be limited to a total of 14 ml. If a subject does not have adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05 mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per surgeon preference. A blinded observer will observe the subject for pain in the PACU using a validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain medications will be noted by an observer in the PACU and followed for the first 24 hours postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral nerve blocks versus local anesthetic infiltration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Block | Experimental | Drug: Bupivacainebilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject |
| local anesthetic infiltration | Experimental | Drug: Bupivacainelocal anesthetic infiltration will be administered after induction of general anesthesia |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All children scheduled for laparoscopic appendectomy between the ages of 6 and 18
- Written informed consent from parent of guardian
Key exclusion criteria (3 listed)
- Sensitivities to local anesthetics
- Significant renal, liver, or cardiac disease
- Appendectomy requiring an open procedure
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 |
|---|---|---|
| BupivacaineThe volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml. | Drug | Peripheral Nerve Block |
| BupivacaineThe volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml. | Drug | local anesthetic infiltration |
Primary outcome
Laparoscopic appendectomy infiltration that reduces postoperative pain
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
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 2 Jul 2013.
- Background: PubMed 8936544Ferguson S, Thomas V, Lewis I. The rectus sheath block in paediatric anaesthesia: new indications for an old technique? Paediatr Anaesth. 1996;6(6):463-6. doi: 10.1046/j.1460-9592.1996.d01-24.x.
- Background: PubMed 16717308Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. doi: 10.1213/01.ane.0000217196.34354.5a.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine in people with Postoperative Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site 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 2 inclusion and 3 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Laparoscopic appendectomy infiltration that reduces postoperative pain (time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours). 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 NCT01662401, which also lists 2 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 2 Jul 2013.