Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03730402
Brief Summary:
This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.
Detailed Description:
Patients will either be pre-screened prior to their pre-operative appointment for eligibility, or screening will occur on the day of surgery. Informed Consent will be obtained from amenable, eligible patients prior to their operation by a member of the research team. A study number will be assigned, and the patient will be randomized to a treatment group. The patients will not be aware to which treatment group they have been randomized.
After consent is obtained and randomization has been completed, the operating room registered nurse will calculate maximum dose of allowable bupivacaine per patient based on body weight. Anesthesia will provide the intravenous lidocaine bolus on induction to all patients without a contraindication to the medication. The port placement will occur using a needle to raise skin/preperitoneal wheal\*. Up to 20cc of 1% lidocaine/epinephrine will be divided among all ports and stab incisions. At end of case, no further skin or port-specific preperitoneal anesthetic will be injected unless a skin incision was extended.
For patients randomized to port site injection (Control): 60 cc of sterile, preservative-free, injectable saline will be given as a placebo per the protocol in item 6.
For patients randomized to bupivacaine plain LAPB (Treatment Arm 1): The maximum weight-based dose of plain bupivacaine will be diluted with sterile, injectable, preservative-free saline to a total of 60cc with a maximum of 250mg bupivacaine (regardless of weight) and loaded into a 30cc syringe with a 22g spinal needle (one 30cc syringe used for each side).
For patients randomized to liposomal bupivacaine LAPB (Treatment Arm 2): The maximum dose for adult patients is 266mg (20mL) of liposomal bupivacaine. This will be diluted with 40cc of preservative-free normal saline for injection, per manufacturer recommendations. The solution will then be loaded into a 30cc syringe with a 22g spinal needle and injected in the same fashion as the bupivacaine plain LAPB.
Data collection will include total doses of IV and skin and block anesthetic used, patient weight, number and size of ports, if fascial closure of port site was conducted, and post-operative narcotic medication used up to 48 hours with timing and doses marked, and use of any pain adjuncts (nonsteroidal anti-inflammatory drugs \[NSAIDs\], acetaminophen, gabapentin, tricyclic antidepressants \[TCA\], pregabalin, clonidine, etc.) although doses of these medications are not to be recorded.
Provision of home narcotic prescription will be based on a standardized protocol developed by Dartmouth. Based on the past 24 hours of pain medication usage, patients will receive either 15 or 30 tablets of hydrocodone/acetaminophen 5/325mg (or liquid equivalent for bariatric patients). Use of narcotic medications at home will be evaluated at 1 week post-procedure by a member of the research team through a phone survey.
Study:
NCT03730402
Study Brief:
Protocol Section:
NCT03730402