Postoperative Pain
Conditions
Brief summary
After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine). Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life). A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously. The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.
Detailed description
The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries (laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures) to one of two groups. Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system placed in a subdiaphragmatic (within the abdomen) location. Half of the study group will have bupivicaine, a numbing medicine in the pump while the other half will have sterile saline in their pump. Neither the patient nor the surgeon will be aware of which group any particular patient is in, this is a process known as blinding and improves the reliability of the results. All patients will receive the standard locally infiltrated trocar site local anesthetic and either a prescription for Vicodin for ambulatory patients or morphine injected into their vein for patients staying in the hospital. All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine. Ambulatory patients will be reached by phone for answers to these questions. All patients will have their pain controlled in the usual and standard way at all times. The On-Q pump will be removed at 48hours. The results will then be statistically reviewed to see if the On-Q pumps were of benefit.
Interventions
DRUGOn-Q Pain Pump
Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Sponsors
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less
Exclusion criteria
* Patients who refuse consent * Are converted from laparoscopy to open surgery * Are allergic to bupivacaine * Are unable to followup
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours | 48 hours postop | Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable). |
Countries
United States
Participant flow
Recruitment details
1 participant randomized to bupivicaine did not complete the study because the participant had to be returned to surgery prior to commencement of study procedures
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine On-Q pump containing Bupivacaine implanted
On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally | 15 |
| Placebo/Control Saline used in the implanted On-Q device | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Bupivacaine | Placebo/Control | Total |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 9.7 | 42.0 years STANDARD_DEVIATION 11.8 | 43.8 years STANDARD_DEVIATION 10.8 |
| Pain Scale | 3.5 units on a scale STANDARD_DEVIATION 0.75 | 3.5 units on a scale STANDARD_DEVIATION 0.75 | 3.5 units on a scale STANDARD_DEVIATION 0.75 |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours
Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Time frame: 48 hours postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine | Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours | 1.7 units on a scale | Standard Deviation 1.94 |
| Placebo/Control | Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours | 3.9 units on a scale | Standard Deviation 2.88 |
p-value: 0.0022t-test, 2 sided