Bowel DiseasePhase 4TAPLIPNCT05224089
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
A Phase 4 study testing Liposomal Bupivicaine/Bupivacaine Admixture and Bupivacaine HCL in people with Bowel Disease, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Disease
- What is being tested?
- Liposomal Bupivicaine/Bupivacaine Admixture and Bupivacaine HCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Kevin J Finkel, MD, kevin.finkel@hhchealth.org
About this study
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.
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.
- Conditions
- Bowel Disease
- Being tested
- Liposomal Bupivicaine/Bupivacaine Admixture, Bupivacaine HCL
- Keywords
- Liposomal Bupivacaine, Exparel, Bupivacaine, Laparoscopic Colectomy, Transverse Abdominis Plane Blocks (TAP), Regional anesthesia, Rectus Sheath Block
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivicaine/Bupivacaine AdmixtureDrug
Also called Bupivacaine
60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL
Bupivacaine HCLDrug
Also called Dexamethasone 0.5 ml (5 mg), Epinephrine 0.1 ml
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine/Bupivacaine HCL | Experimental | 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. Receives: Drug: Liposomal Bupivicaine/Bupivacaine Admixture; Drug: Bupivacaine HCL |
| Regular Bupivacaine Arm | Active comparator | 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. Receives: Drug: Bupivacaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The highest Numerical Pain Scores
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
Measured: 3 days
Secondary outcomes (9)
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.
Measured: up to 3 days
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.
Measured: up to 72 postoperative hours
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.
Measured: 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.
Measured: 30 days
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.
Measured: 6 days
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.
Measured: Pre-block intervention, immediately after surgery, up to 3 days
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.
Measured: On the day of first postoperative visit, the end of the 6th and 12th postoperative months
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.
Measured: Up to 30 postoperative days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start27 Apr 2022
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Bowel DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, prospective, triple blinded, randomized, controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Finkel, Hartford Hospital
- Investigators
- Kevin Finkel, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224089
- Sponsor's protocol ID
- HHC-2021-0331
- Acronym
- TAPLIP
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25.
PubMed 28742435Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
PubMed 20116145Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.
PubMed 28059913Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4.
PubMed 31797098Smith SR, Draganic B, Pockney P, Holz P, Holmes R, Mcmanus B, Carroll R. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial. Int J Colorectal Dis. 2015 Sep;30(9):1237-45. doi: 10.1007/s00384-015-2286-7. Epub 2015 Jun 24.
PubMed 26099316Qazi N, Bhat WM, Iqbal MZ, Wani AR, Gurcoo SA, Rasool S. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial. Anesth Essays Res. 2017 Jul-Sep;11(3):767-772. doi: 10.4103/0259-1162.194577.
PubMed 28928585Erratum to highlighted version successful resection of a tracheal metastasis of rectal cancer: a case report. J Thorac Dis. 2017 Oct;9(10):E978. doi: 10.21037/jtd.2017.10.137.
PubMed 29266106Liu L, Xie YH, Zhang W, Chai XQ. Effect of Transversus Abdominis Plane Block on Postoperative Pain after Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials. Med Princ Pract. 2018;27(2):158-165. doi: 10.1159/000487323. Epub 2018 Feb 1.
PubMed 29402875Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
PubMed 23049275Keller DS, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. Surg Endosc. 2016 Jun;30(6):2192-8. doi: 10.1007/s00464-015-4459-4. Epub 2015 Aug 15.
PubMed 26275549Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.
PubMed 27238859Hutchins J, Argenta P, Berg A, Habeck J, Kaizer A, Geller MA. Ultrasound-guided subcostal transversus abdominis plane block with liposomal bupivacaine compared to bupivacaine infiltration for patients undergoing robotic-assisted and laparoscopic hysterectomy: a prospective randomized study. J Pain Res. 2019 Jul 4;12:2087-2094. doi: 10.2147/JPR.S193872. eCollection 2019.
PubMed 31308734Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005 Apr 20;5:13. doi: 10.1186/1471-2288-5-13.
PubMed 15840177Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
PubMed 25524443Horlocker TT, Vandermeuelen E, Kopp SL, Gogarten W, Leffert LR, Benzon HT. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition). Reg Anesth Pain Med. 2018 Apr;43(3):263-309. doi: 10.1097/AAP.0000000000000763. No abstract available.
PubMed 29561531
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05224089
- Acronym / sponsor ID
- TAPLIP / HHC-2021-0331
- Conditions
- Bowel Disease
- Keywords
- Liposomal Bupivacaine, Exparel, Bupivacaine, Laparoscopic Colectomy, Transverse Abdominis Plane Blocks (TAP), Regional anesthesia, Rectus Sheath Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 4 Feb 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, prospective, triple blinded, randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine/Bupivacaine HCL | Experimental | Drug: Liposomal Bupivicaine/Bupivacaine Admixture, Drug: Bupivacaine HCL20mL 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. |
| Regular Bupivacaine Arm | Active comparator | Drug: Bupivacaine HCL80mL 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Liposomal Bupivicaine/Bupivacaine AdmixtureAlso: Bupivacaine60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL | Drug | Liposomal Bupivacaine/Bupivacaine HCL |
| Bupivacaine HCLAlso: Dexamethasone 0.5 ml (5 mg), Epinephrine 0.1 ml80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL | Drug | Liposomal Bupivacaine/Bupivacaine HCL, Regular Bupivacaine Arm |
Primary outcome
The highest Numerical Pain Scores
Time frame: 3 days
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
9 secondary outcomes
The highest Numerical Pain Scores for the period of 0-47 hours
Time frame: up to 3 days
All pain scores, mild-moderate-severe.
Time frame: up to 72 postoperative hours
Postoperative opioid consumption measured in morphine MilliEquivalent (MME)
Time frame: Up to 6 days post surgery.
Postoperative nausea/vomiting scores
Time frame: 30 days
Hospital and post-anesthesia care unit length of stay
Time frame: 6 days
Duration of the study block using the sensory function test
Time frame: Pre-block intervention, immediately after surgery, up to 3 days
Brief Pain Inventory (Short Form)
Time frame: On the day of first postoperative visit, the end of the 6th and 12th postoperative months
Block complications
Time frame: Up to 30 postoperative days
Patient Overall Satisfaction
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 28742435Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25.
- Background: PubMed 20116145Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
- Background: PubMed 28059913Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.
- Background: PubMed 31797098Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4.
- Background: PubMed 26099316Smith SR, Draganic B, Pockney P, Holz P, Holmes R, Mcmanus B, Carroll R. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial. Int J Colorectal Dis. 2015 Sep;30(9):1237-45. doi: 10.1007/s00384-015-2286-7. Epub 2015 Jun 24.
- Background: PubMed 28928585Qazi N, Bhat WM, Iqbal MZ, Wani AR, Gurcoo SA, Rasool S. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial. Anesth Essays Res. 2017 Jul-Sep;11(3):767-772. doi: 10.4103/0259-1162.194577.
- Background: PubMed 29266106Erratum to highlighted version successful resection of a tracheal metastasis of rectal cancer: a case report. J Thorac Dis. 2017 Oct;9(10):E978. doi: 10.21037/jtd.2017.10.137.
- Background: PubMed 29402875Liu L, Xie YH, Zhang W, Chai XQ. Effect of Transversus Abdominis Plane Block on Postoperative Pain after Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials. Med Princ Pract. 2018;27(2):158-165. doi: 10.1159/000487323. Epub 2018 Feb 1.
- Background: PubMed 23049275Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
- Background: PubMed 26275549Keller DS, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. Surg Endosc. 2016 Jun;30(6):2192-8. doi: 10.1007/s00464-015-4459-4. Epub 2015 Aug 15.
- Background: PubMed 27238859Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.
- Background: PubMed 31308734Hutchins J, Argenta P, Berg A, Habeck J, Kaizer A, Geller MA. Ultrasound-guided subcostal transversus abdominis plane block with liposomal bupivacaine compared to bupivacaine infiltration for patients undergoing robotic-assisted and laparoscopic hysterectomy: a prospective randomized study. J Pain Res. 2019 Jul 4;12:2087-2094. doi: 10.2147/JPR.S193872. eCollection 2019.
- 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.govLink provided by the sponsor.
- 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.
Kevin Finkel, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivicaine/Bupivacaine Admixture and Bupivacaine HCL in people with Bowel Disease, run by Hartford Hospital 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aseel Walker, MD (860-972-1778, aseel.walker@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The highest Numerical Pain Scores (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224089, which also lists 20 linked publications.
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 2 Apr 2025.