Postoperative PainNCT02945696
Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
A study testing laparoscopic guided nerve blocks and Ropivacaine in people with Postoperative Pain, run by Marcus Malek.
Trial summary
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- laparoscopic guided nerve blocks and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2020
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 5 - 17 years old.
- Patients undergoing laparoscopic procedures
- Patients that weigh greater than or equal to 34 kg and less than 100 kg.
Who cannot join
- Patients who underwent open surgical procedures will be excluded from this study.
- Patients that weigh less than 34kg.
- Patients that weigh more than 100 kg.
- Perforated appendicitis.
- Bowel obstruction
About this study
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
Read the detailed description
Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.
- Conditions
- Postoperative Pain
- Being tested
- laparoscopic guided nerve blocks, Ropivacaine
- Keywords
- nerve block, laparoscopy, anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic guided nerve blocksProcedure or surgery
It is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children.
RopivacaineDrug
Ropivacaine is a local anesthetic used to prevent pain during and after procedures. In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Local port site injection | No intervention | Not described |
| Ultrasound-guided nerve blocks | No intervention | Not described |
| Laparoscopic guided nerve blocks | Experimental | These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy. Receives: Procedure: laparoscopic guided nerve blocks; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes under anesthesia
Measured: 2 years
Secondary outcomes (2)
Pain scores
Measured: 2 years
Narcotic usage
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Malek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcus Malek, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945696
- Sponsor's protocol ID
- PRO16050059
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
- ClinicalTrials.gov ID
- NCT02945696
- Acronym / sponsor ID
- PRO16050059
- Conditions
- Postoperative Pain
- Keywords
- nerve block, laparoscopy, anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marcus MalekUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 26 Oct 2016 (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 investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
Detailed description
Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local port site injection | No intervention | – |
| Ultrasound-guided nerve blocks | No intervention | – |
| Laparoscopic guided nerve blocks | Experimental | Procedure: laparoscopic guided nerve blocks, Drug: RopivacaineThese patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients 5 - 17 years old.
- Patients undergoing laparoscopic procedures
- Patients that weigh greater than or equal to 34 kg and less than 100 kg.
Key exclusion criteria (5 listed)
- Patients who underwent open surgical procedures will be excluded from this study.
- Patients that weigh less than 34kg.
- Patients that weigh more than 100 kg.
- Perforated appendicitis.
- Bowel obstruction
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 |
|---|---|---|
| laparoscopic guided nerve blocksIt is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children. | Procedure or surgery | Laparoscopic guided nerve blocks |
| RopivacaineRopivacaine is a local anesthetic used to prevent pain during and after procedures. In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance. | Drug | Laparoscopic guided nerve blocks |
Primary outcome
Minutes under anesthesia
Time frame: 2 years
2 secondary outcomes
Pain scores
Time frame: 2 years
Narcotic usage
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic guided nerve blocks and Ropivacaine in people with Postoperative Pain, run by Marcus Malek.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Minutes under anesthesia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2020.