Laparoscopic CholecystectomyNCT03022279
Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children
A study testing TAP Blocks and local wound infiltration in people with Laparoscopic Cholecystectomy, run by Brian Wallace Gray at 1 site in United States.
Trial summary
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- TAP Blocks and local 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
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to Sep 2022
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-17 yrs of age at date of enrollment.
- Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.
Who cannot join
- Chronic pain or chronic use of narcotic or other prescription pain medications.
- Use of pain medication within 24 hours before surgery
- Prior major abdominal surgery
- Evidence of acute inflammation
- Patients with acute cholecystitis
- Bleeding / coagulation disorder
Show all 18Show fewer
- Seizure disorder
- Renal dysfunction
- Infection at injection sites for TAP block or trocar placement
- Contraindication to LWI or TAP block procedure, as determined by surgeon or anesthesiologist performing the procedure (including, but not limited to, previous incision distorting anatomy or inability to visualize anatomical planes)
- Any known allergy to medications used in this study
- Patient unable to verbalize pain score or independently assess pain level
- Unstable patient in need of emergent intervention at surgeon discretion
- Patients who are known to be pregnant
- Patients who are currently prisoners
- Children in custody of the state
- Subjects will a BMI >/= 50
- Investigator discretion for any other reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
Official title: Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.
Read the detailed description
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- TAP Blocks, local wound infiltration
- Keywords
- Pediatric, post-operative pain prevention, Anesthesia, Infiltration, Nerve Blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlocksProcedure or surgery
Also called nerve block, transversus abdominis plane block
ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
local wound infiltrationProcedure or surgery
Also called local wound injections
local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| TAP blocks | Active comparator | TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites). Receives: Procedure: TAP Blocks |
| Local Wound Infiltration | Active comparator | Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis. Receives: Procedure: local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of narcotic pain medication
Measured: 24 hours post-op
Time to first request of pain medication
Measured: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start6 Jan 2017
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Wallace Gray
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Wallace Gray, Indiana University
- Investigators
- Gray Brian, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022279
- Sponsor's protocol ID
- 1410511719
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2016
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT03022279
- Acronym / sponsor ID
- 1410511719
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Pediatric, post-operative pain prevention, Anesthesia, Infiltration, Nerve Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Brian Wallace GrayUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 16 Jan 2017 (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 objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.
Detailed description
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP blocks | Active comparator | Procedure: TAP BlocksTAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites). |
| Local Wound Infiltration | Active comparator | Procedure: local wound infiltrationLocal wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 8-17 yrs of age at date of enrollment.
- Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.
Key exclusion criteria (18 listed)
- Chronic pain or chronic use of narcotic or other prescription pain medications.
- Use of pain medication within 24 hours before surgery
- Prior major abdominal surgery
- Evidence of acute inflammation
- Patients with acute cholecystitis
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 |
|---|---|---|
| TAP BlocksAlso: nerve block, transversus abdominis plane blockultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine | Procedure or surgery | TAP blocks |
| local wound infiltrationAlso: local wound injectionslocal anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine | Procedure or surgery | Local Wound Infiltration |
Primary outcome
Amount of narcotic pain medication
Time frame: 24 hours post-op
Time to first request of pain medication
Time frame: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
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 3 Mar 2023.
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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.
Gray Brian, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Blocks and local wound infiltration in people with Laparoscopic Cholecystectomy, run by Brian Wallace Gray 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 18 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 3 Mar 2023. 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.
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?
Amount of narcotic pain medication (time frame: 24 hours post-op). The study lists 2 primary outcomes in all. 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 3 Mar 2023.