Anesthesia, Local, Opioid Use, Pain, Postoperative
Conditions
Keywords
Wound infiltration, Post Cesarean, Pain management, bupivacaine, dexmedetomidine, postoperative pain
Brief summary
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
Detailed description
The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.
Interventions
DRUGBupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
DRUGDexmedetomidine
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
DRUGPlacebo
Injection of a placebo into the surgical wound
Sponsors
Richmond University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* All scheduled Cesarean deliveries with intrathecal or epidural anesthesia
Exclusion criteria
* Emergency Cesarean deliveries * Multifetal gestation * Subjects \<18 years old * Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners) * Cesarean delivery with general anesthesia * Known allergy or hypersensitivity to any of the study medications * Subjects that can't comprehend the visual analog scale for quantitative pain assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of opioid free Cesarean deliveries | 1 year | Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia | 0 hour post-cesarean to time rescue analgeisa is administered] | Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered |
| Total opioid consumption | 0-14 days | Measure the subjects total opioid consumption for the total duration of the postoperative course. |
| Side effects/Adverse reactions | 0-14 days | Measure any side effects/allergic reactions attributed to use of any of the study drugs. |
| Postoperative hospital stay | 0-14days | Measure the length of the post-operative hospital stay . |
| Complications from procedures | 0-14 days | Measure any complications associated with the wound infiltration procedure |
| Breast feeding capacity | 0-14 days | Assess the subject's capacity to breast feed during the postoperative course |
Countries
United States
Contacts
Primary ContactNisha Lakhi, MD
Outcome results
None listed