Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
Primary Purpose
Postoperative Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic guided nerve blocks
Ropivacaine
Sponsored by
About this trial
This is an interventional health services research trial for Postoperative Pain focused on measuring nerve block, laparoscopy, anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients 5 - 17 years old.
- Patients undergoing laparoscopic procedures
- Patients that weigh greater than or equal to 34 kg and less than 100 kg.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
Local port site injection
Ultrasound-guided nerve blocks
Laparoscopic guided nerve blocks
Arm Description
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.
Outcomes
Primary Outcome Measures
Minutes under anesthesia
Secondary Outcome Measures
Pain scores
Narcotic usage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02945696
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Funding issues
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcus Malek
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
nerve block, laparoscopy, anesthesia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local port site injection
Arm Type
No Intervention
Arm Title
Ultrasound-guided nerve blocks
Arm Type
No Intervention
Arm Title
Laparoscopic guided nerve blocks
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic guided nerve blocks
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Minutes under anesthesia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pain scores
Time Frame
2 years
Title
Narcotic usage
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 5 - 17 years old.
Patients undergoing laparoscopic procedures
Patients that weigh greater than or equal to 34 kg and less than 100 kg.
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
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