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Local Anesthetic
TAP Block for Postoperative Pain After Gallbladder Surgery
Phase 3
Waitlist Available
Led By Karen Boretsky, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age 5-17 years old at time of surgery
Patients scheduled for laparoscopic cholecystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
This trial will compare two methods of pain relief after laparoscopic cholecystectomy: ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline vs. ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine.
Who is the study for?
This trial is for children aged 5-17 undergoing laparoscopic cholecystectomy with a low risk of complications (ASA status 1-2). They must be staying in the hospital for at least 24 hours post-surgery and able to communicate pain. Those with infections, substance abuse, significant organ disease, neurocognitive issues, allergies to local anesthetics or NSAIDs, opioid use, or non-English speaking cannot participate.Check my eligibility
What is being tested?
The study tests if ultrasound-guided nerve blocks using ropivacaine are better than standard local wound infiltration for reducing pain after gallbladder removal surgery. Patients will be randomly assigned to receive either the nerve block with ropivacaine and saline or just saline plus local anesthetic infiltration.See study design
What are the potential side effects?
Possible side effects include discomfort at injection site, allergic reactions to ropivacaine or other medications used during the procedure. There's also a small risk of infection from the injections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 and 17 years old and need surgery.
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I am scheduled for a gallbladder removal surgery using a camera.
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My surgery will only be a laparoscopic gallbladder removal.
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My parent can consent for me and I can agree to participate if I'm older than 7.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
cumulative opioid consumption (both intravenous and enteral) during the perioperative period
Secondary outcome measures
overall patient functional recovery evidenced by validated patient surveys
post-operative episodes of opioid-related side effects, such as nausea, vomiting, constipation, urinary retention, and pruritis
post-operative patient-reported pain scores upon arrival to the post-operative care unit and inpatient unit
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Surgical Infiltration with Ropivacaine 0.5%Active Control5 Interventions
Patients will receive surgical infiltration of local anesthetic into the 4 laparoscopic port sites. A total of 0.4 ml/kg (0.1+0.1+0.1+0.1) of 0.5% Ropivacaine, divided between the four port sites (max 20 ml), will be used. A total of 1ml/kg, divided between the TAP (0.4ml/kg on each side) and RS (0.1ml/kg on each side), of sterile saline will be used for the nerve blocks.
Group II: Abdominal Wall Block with Ropivacaine 0.2%Active Control5 Interventions
Patients will receive bilateral transversus abdominis plane and rectus sheath blocks via ultrasound guidance. A total of 1.0ml/kg distributed between the four blocks (0.4+0.4+0.1+0.1) of 0.2% Ropivacaine (max 50ml) will be injected, as a one time single shot injection, into the fours sites. Surgical infiltration of the four port sites will receive 0.4ml/kg of sterile saline.
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,650 Total Patients Enrolled
3 Trials studying Postoperative Pain
145 Patients Enrolled for Postoperative Pain
Karen Boretsky, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 5 and 17 years old and need surgery.I am scheduled for a gallbladder removal surgery using a camera.I have severe liver or kidney disease.I have a blood clotting disorder.I have an active infection where a nerve block would be placed.I have a condition that makes it hard for me to communicate pain.You take opioid medication every day.My surgery will only be a laparoscopic gallbladder removal.You have had an allergic reaction to numbing medicine or certain painkillers.You have a severe medical condition classified as ASA class 3 or higher.My parent can consent for me and I can agree to participate if I'm older than 7.I have been diagnosed with chronic pain syndrome.I will need intensive care or a breathing tube after my surgery.I had emergency gallbladder removal surgery or it was changed to an open surgery.You have had problems with drinking too much alcohol or using drugs in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Infiltration with Ropivacaine 0.5%
- Group 2: Abdominal Wall Block with Ropivacaine 0.2%
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary medical purpose of Abdominal Wall Block with Ropivacaine 0.2%?
"Abdominal Wall Block with Ropivacaine 0.2% can be used for surgical anesthesia, pain during childbirth, and other medical procedures that require anesthesia."
Answered by AI
Does this research involve elderly individuals?
"Children aged 5-17 years old are being recruited for this clinical trial."
Answered by AI
What are the side effects of using Ropivacaine 0.2% for an abdominal block?
"There is extensive clinical data supporting the safety of abdominal wall block with ropivacaine 0.2%, thus it received a score of 3."
Answered by AI
Does this research project still have room for new participants?
"Unfortunately, this particular trial is not accepting patients at this moment in time. However, there are 609 other trials that are seeking participants."
Answered by AI
Who meets the eligibility requirements for participation in this research project?
"This study aims to enroll 80 children aged 5-17 who have postoperative pain. To be eligible, candidates must have undergone laparoscopic cholecystectomy, have an ASA status of 1 or 2, and be either admitted to the hospital for 24 hours or have a parent that can provide informed consent. Patients who are aged 7 or above must also be able to provide assent."
Answered by AI
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