A Phase 4 interventional study of Liposomal Bupivicaine/Bupivacaine Admixture and Bupivacaine HCL in Bowel Disease, sponsored by Hartford Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Hartford Hospital · Phase 4, Interventional, and Treatment
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.
260 studies on the registry are indexed under Intestinal Diseases; 53 are open to participants now.
This study's planned enrollment of 114 is above the median of 67 across 180 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Liposomal Bupivicaine/Bupivacaine Admixture · Drug: Bupivacaine HCL
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.
Drug: Bupivacaine HCL
Drug page: Bupivacaine
60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL
Also known as: Bupivacaine
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL
Also known as: Dexamethasone 0.5 ml (5 mg), Epinephrine 0.1 ml
The highest Numerical Pain Scores
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
Time frame: 3 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Nov 2025, 43 months after the start.
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Studies of the drug tested here: Bupivacaine