Randomized double-blind placebo-controlled study of the efficacy of continuous infusion of local anesthetic to the diaphragm closure following laparoscopic hiatal hernia repair.
Summary of "Randomized double-blind placebo-controlled study of the efficacy of continuous infusion of local anesthetic to the diaphragm closure following laparoscopic hiatal hernia repair."
BACKGROUND:
Laparoscopic repair of hiatal hernia can result in significant postoperative pain requiring use of narcotics and patient dissatisfaction. A catheter-based delivery method that has demonstrated effectiveness and safety in other laparoscopic and open procedures (ON-Q, I Flow Corporation) was used to deliver pain medicine. This randomized double-blind, placebo-controlled study evaluated the efficacy of continuous infusion of local anesthetic to the diaphragm closure post laparoscopic hiatal hernia repair.
METHODS:
After obtaining Institutional Review Board approval, qualifying patients undergoing laparoscopic repair of hiatal hernia voluntarily consented to the study protocol. Standard techniques for routine closure of hiatal hernia repair were used. The ON-Q pain pump catheter was placed adjacent to the sutures used to repair the hiatal hernia, so that it rested between the diaphragm and the collagen patch used to reinforce the hernia repair. The pump infused either bupivacaine 0.5% or NaCl 0.9% at 2 cc/h for 5 days postoperatively. Patients kept a daily diary for pain scores, number of narcotic pain pills taken, and number of nausea pills taken.
RESULTS:
Of the 46 patients enrolled in the study, seven were dropped for adverse events or noncompliance; 20 were given placebo (0.9% NaCl) and 19 were given 0.5% bupivacaine.
CONCLUSION:
This randomized double-blind, placebo-controlled trial showed no advantage in using the ON-Q pain pump in terms of providing measurable reduction of pain or concomitant narcotic or nausea medication use. Further studies are indicated to determine alternatives for reducing postoperative pain after laparoscopic hiatal hernia repair.
Affiliation
Swedish Medical Center and SurgOne P.C., 401 W Hampden Place, Suite 230, Englewood, CO, 80110, USA, rbell@surgone.com.
Journal Details
This article was published in the following journal.
Name: Surgical endoscopy
ISSN: 1432-2218
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22437952
- DOI: http://dx.doi.org/10.1007/s00464-012-2219-2
Medical and Biotech [MESH] Definitions
Clinical Trial, Phase I
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Clinical Trial, Phase Ii
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Clinical Trial, Phase Iii
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Intention To Treat Analysis
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Multicenter Study
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