Phase 4
Completed N=30
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Source: ClinicalTrials.gov NCT00533845 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours — 1.7; 3.9 units on a scale — p=.0022
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours |
1.7; 3.9 | .0022 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00533845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.