Back to resultsBilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy (TAPLIP)
Primary Purpose
Bowel Disease
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivicaine/Bupivacaine Admixture
Bupivacaine HCL
Sponsored by
About this trial
This is an interventional treatment trial for Bowel Disease focused on measuring Liposomal Bupivacaine, Exparel, Bupivacaine, Laparoscopic Colectomy, Transverse Abdominis Plane Blocks (TAP), Regional anesthesia, Rectus Sheath Block
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
- English speaking patients
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
Exclusion Criteria:
- Emergency laparoscopic colectomy surgery
- Patients with distant metastatic cancers (e.g. bone, lung, brain).
- Scheduled for multi organs resection surgery in addition to colectomy.
- Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
- Current colostomies.
- History of allergy to local anesthetics.
- Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
- Weight < 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
- Patients who take long acting opioid medication, or on continuous opioid > 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
- Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15
- Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
- Refusal or lack of providing the study consent
Sites / Locations
- Hartford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine/Bupivacaine HCL
Regular Bupivacaine Arm
Arm Description
20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Outcomes
Primary Outcome Measures
The highest Numerical Pain Scores
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
Secondary Outcome Measures
The highest Numerical Pain Scores for the period of 0-47 hours
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery by patients in the two groups, using the Brief Pain Inventory (Short Form), this measurement will be done at the 26th and 50th postoperative hour with a range on +3/-2 hours.
All pain scores, mild-moderate-severe.
Proportion of patients experiencing moderate or severe pain, the scores will be grouped such that 1-3 is considered mild pain, 4-6 moderate pain, and 7-10 severe pain.
Postoperative opioid consumption measured in morphine MilliEquivalent (MME)
Postoperative total opioid consumption measured in morphine MilliEquivalent (MME) will be collected starting from the time in post-anaesthesia care unit up to the first 6 postoperative days. Patients will continue to report their opioid consumption after discharge days using the pain and medication diary up to 6 days post-surgery.
Postoperative nausea/vomiting scores
Using a validated measure; the Simplified (Post-operative nausea and vomiting Impact Scale 17 which consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This form will be completed either by the assigned nurse or the study coordinator immediately after surgery in the post-anesthesia care unit, postoperative day#1, postoperative day#2, postoperative day#3, and during the first follow up visit.
Hospital and post-anesthesia care unit length of stay
Hospital length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records. post-anesthesia care unit length of stay will be calculated in minutes using the post-anesthesia care unit data collection sheet and from the electronic medical records.
Duration of the study block using the sensory function test
The preoperative sensory function test will be assessed prior to the block by the anesthesiologist performing the block while the postoperative assessment at the post-anesthesia care unit will be used as baseline to be compared with the following sensory tests to assess the duration of sensory nerve block, using post-anesthesia care unit and In-Patient Post-Operative Data Collection Sheet.
Brief Pain Inventory (Short Form)
A validated scale that rapidly assesses pain severity and its impact on functioning. It consists of a 2-page questionnaire that asks patients to report the location and severity of their pain, and to report the interference of pain, if any, on their activities over the previous 24 hours. Four questions ask patients to rate the severity of their pain on a scale of 1-10 over the previous 24 hours in 4 discrete categories: worst, least, average, and right now. Each rating is analyzed separately. Seven questions ask patients to rate how severely their pain has interfered with their general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 1-10 over the previous 24 hours. These 7 questions are scored as a mean of the answers given, as long as at least 4 questions are answered. Two other questions ask patients to list the treatments or medications they are currently using, and to rate how much relief these are providing.
Block complications
The occurrence of block complications will be collected intraoperative and postoperative period including post-anesthesia care unit, daily in patient period, the day of discharge, and at the time of the post-operative follow-up visit. Readmissions within 30 days after discharge will also be collected.
Patient Overall Satisfaction
A scale from 0 = very dissatisfied to 10 = very satisfied, this will be evaluated on day of discharge and on the first postoperative clinic visit either in person or through a phone call.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224089
Brief Title
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
Acronym
TAPLIP
Official Title
Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Disease
Keywords
Liposomal Bupivacaine, Exparel, Bupivacaine, Laparoscopic Colectomy, Transverse Abdominis Plane Blocks (TAP), Regional anesthesia, Rectus Sheath Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
single-center, prospective, triple blinded, randomized, controlled trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine/Bupivacaine HCL
Arm Type
Experimental
Arm Description
20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Arm Title
Regular Bupivacaine Arm
Arm Type
Active Comparator
Arm Description
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivicaine/Bupivacaine Admixture
Other Intervention Name(s)
Bupivacaine
Intervention Description
60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCL
Other Intervention Name(s)
Dexamethasone 0.5 ml (5 mg), Epinephrine 0.1 ml
Intervention Description
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL
Primary Outcome Measure Information:
Title
The highest Numerical Pain Scores
Description
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
The highest Numerical Pain Scores for the period of 0-47 hours
Description
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery by patients in the two groups, using the Brief Pain Inventory (Short Form), this measurement will be done at the 26th and 50th postoperative hour with a range on +3/-2 hours.
Time Frame
up to 3 days
Title
All pain scores, mild-moderate-severe.
Description
Proportion of patients experiencing moderate or severe pain, the scores will be grouped such that 1-3 is considered mild pain, 4-6 moderate pain, and 7-10 severe pain.
Time Frame
up to 72 postoperative hours
Title
Postoperative opioid consumption measured in morphine MilliEquivalent (MME)
Description
Postoperative total opioid consumption measured in morphine MilliEquivalent (MME) will be collected starting from the time in post-anaesthesia care unit up to the first 6 postoperative days. Patients will continue to report their opioid consumption after discharge days using the pain and medication diary up to 6 days post-surgery.
Time Frame
Up to 6 days post surgery.
Title
Postoperative nausea/vomiting scores
Description
Using a validated measure; the Simplified (Post-operative nausea and vomiting Impact Scale 17 which consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This form will be completed either by the assigned nurse or the study coordinator immediately after surgery in the post-anesthesia care unit, postoperative day#1, postoperative day#2, postoperative day#3, and during the first follow up visit.
Time Frame
30 days
Title
Hospital and post-anesthesia care unit length of stay
Description
Hospital length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records. post-anesthesia care unit length of stay will be calculated in minutes using the post-anesthesia care unit data collection sheet and from the electronic medical records.
Time Frame
6 days
Title
Duration of the study block using the sensory function test
Description
The preoperative sensory function test will be assessed prior to the block by the anesthesiologist performing the block while the postoperative assessment at the post-anesthesia care unit will be used as baseline to be compared with the following sensory tests to assess the duration of sensory nerve block, using post-anesthesia care unit and In-Patient Post-Operative Data Collection Sheet.
Time Frame
Pre-block intervention, immediately after surgery, up to 3 days
Title
Brief Pain Inventory (Short Form)
Description
A validated scale that rapidly assesses pain severity and its impact on functioning. It consists of a 2-page questionnaire that asks patients to report the location and severity of their pain, and to report the interference of pain, if any, on their activities over the previous 24 hours. Four questions ask patients to rate the severity of their pain on a scale of 1-10 over the previous 24 hours in 4 discrete categories: worst, least, average, and right now. Each rating is analyzed separately. Seven questions ask patients to rate how severely their pain has interfered with their general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 1-10 over the previous 24 hours. These 7 questions are scored as a mean of the answers given, as long as at least 4 questions are answered. Two other questions ask patients to list the treatments or medications they are currently using, and to rate how much relief these are providing.
Time Frame
On the day of first postoperative visit, the end of the 6th and 12th postoperative months
Title
Block complications
Description
The occurrence of block complications will be collected intraoperative and postoperative period including post-anesthesia care unit, daily in patient period, the day of discharge, and at the time of the post-operative follow-up visit. Readmissions within 30 days after discharge will also be collected.
Time Frame
Up to 30 postoperative days
Title
Patient Overall Satisfaction
Description
A scale from 0 = very dissatisfied to 10 = very satisfied, this will be evaluated on day of discharge and on the first postoperative clinic visit either in person or through a phone call.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
English speaking patients
Patients with American Society of Anesthesiology (ASA) physical status score I- IV
Exclusion Criteria:
Emergency laparoscopic colectomy surgery
Patients with distant metastatic cancers (e.g. bone, lung, brain).
Scheduled for multi organs resection surgery in addition to colectomy.
Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
Current colostomies.
History of allergy to local anesthetics.
Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
Weight < 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
Patients who take long acting opioid medication, or on continuous opioid > 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15
Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
Refusal or lack of providing the study consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aseel Walker, MD
Phone
860-972-1778
Email
aseel.walker@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Finkel, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin J Finkel, MD
Email
kevin.finkel@hhchealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://health.gov/dietaryguidelines/2015/guidelines/
Description
Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. Morbidity and Mortality Weekly Report (MMWR) Recommendations and Reports 2016; 65 2015-2020 Dietary Guidelines - health.gov
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Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
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