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The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: a double-blind, randomized, placebo-controlled study

E. Aasvang, J. Hansen, J. Malmstrom, T. Asmussen, D. Gennevois, Michel Struys UGent and H. Kehlet (2008) Anesthesia and Analgesia. 107(1). p.282-291
abstract
BACKGROUND: Acute postoperative pain is common after most surgical procedures. Despite the availability of many analgesic options, postoperative pain management is often unsatisfactory. Purified capsaicin (ALGRX 4975 98% pure) has demonstrated prolong inhibition of C-fiber function in in vitro, preclinical, and clinical studies, and may be an effective adjunct to postoperative pain management. METHODS: We performed a single-center, randomized, double-blind, placebo-controlled study of the analgesic efficacy of a single intraoperative wound instillation of 1000 mu g ultrapurified capsaicin (ALGRX 4975) after open mesh groin hernia repair in 41 adult male patients. The primary end-point was average daily visual analog scale (VAS) pain scores during the first week after surgery assessed as area under the curve (AUC). Pain was recorded twice daily in a pain diary for 4 wk. Physical examination and laboratory tests were done before and I wk after surgery, together with recordings of adverse events up to 28 days. Adverse events were recorded. Data were also analyzed using a mixed-effects analysis with NONMEM. RESULTS: VAS AUC was significantly lower during the first 3 days postoperatively (P < 0.05), but not for the whole I or 4 wk postoperatively. Mixed-effects analysis with NONMEM revealed that pain scores were significantly lower (P < 0.05) in the capsaicin group during the first 4 days. No clinically significant serious adverse events were observed, although a mild transient increase in liver enzymes was seen more often in the capsaicin-treated group. CONCLUSION: In the setting of a well-defined analgesic protocol standard, VAS AUC analysis and a mixed-effect analysis showed superior analgesia of capsaicin relative to placebo during the first 3-4 days after inguinal hernia repair.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
POSTOPERATIVE PAIN, CONTROLLED-TRIAL, INTRADERMAL INJECTION, TOPICAL CAPSAICIN, EPIDERMAL NERVE-FIBERS, INGUINAL-HERNIA REPAIR, LOCAL-ANESTHETIC INFUSION, HUMANS, HERNIORRHAPHY, HYPERALGESIA
journal title
Anesthesia and Analgesia
Anesth. Analg.
volume
107
issue
1
pages
282 - 291
publisher
LIPPINCOTT WILLIAMS & WILKINS,
place of publication
530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA
Web of Science type
Article
Web of Science id
000257097100043
JCR category
ANESTHESIOLOGY
JCR impact factor
2.59 (2008)
JCR rank
6/22 (2008)
JCR quartile
2 (2008)
ISSN
0003-2999
DOI
10.1213/ane.0b013e31816b94c9
language
English
UGent publication?
yes
classification
A1
copyright statement
I have retained and own the full copyright for this publication
id
528469
handle
http://hdl.handle.net/1854/LU-528469
date created
2009-03-23 16:30:20
date last changed
2009-03-25 16:02:47
@article{528469,
  abstract     = {BACKGROUND: Acute postoperative pain is common after most surgical procedures. Despite the availability of many analgesic options, postoperative pain management is often unsatisfactory. Purified capsaicin (ALGRX 4975 98\% pure) has demonstrated prolong inhibition of C-fiber function in in vitro, preclinical, and clinical studies, and may be an effective adjunct to postoperative pain management.
METHODS: We performed a single-center, randomized, double-blind, placebo-controlled study of the analgesic efficacy of a single intraoperative wound instillation of 1000 mu g ultrapurified capsaicin (ALGRX 4975) after open mesh groin hernia repair in 41 adult male patients. The primary end-point was average daily visual analog scale (VAS) pain scores during the first week after surgery assessed as area under the curve (AUC). Pain was recorded twice daily in a pain diary for 4 wk. Physical examination and laboratory tests were done before and I wk after surgery, together with recordings of adverse events up to 28 days. Adverse events were recorded. Data were also analyzed using a mixed-effects analysis with NONMEM.

RESULTS: VAS AUC was significantly lower during the first 3 days postoperatively (P {\textlangle} 0.05), but not for the whole I or 4 wk postoperatively. Mixed-effects analysis with NONMEM revealed that pain scores were significantly lower (P {\textlangle} 0.05) in the capsaicin group during the first 4 days. No clinically significant serious adverse events were observed, although a mild transient increase in liver enzymes was seen more often in the capsaicin-treated group.

CONCLUSION: In the setting of a well-defined analgesic protocol standard, VAS AUC analysis and a mixed-effect analysis showed superior analgesia of capsaicin relative to placebo during the first 3-4 days after inguinal hernia repair.},
  author       = {Aasvang, E. and Hansen, J. and Malmstrom, J. and Asmussen, T. and Gennevois, D. and Struys, Michel and Kehlet, H.},
  issn         = {0003-2999},
  journal      = {Anesthesia and Analgesia},
  keyword      = {POSTOPERATIVE PAIN,CONTROLLED-TRIAL,INTRADERMAL INJECTION,TOPICAL CAPSAICIN,EPIDERMAL NERVE-FIBERS,INGUINAL-HERNIA REPAIR,LOCAL-ANESTHETIC INFUSION,HUMANS,HERNIORRHAPHY,HYPERALGESIA},
  language     = {eng},
  number       = {1},
  pages        = {282--291},
  publisher    = {LIPPINCOTT WILLIAMS \& WILKINS,},
  title        = {The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: a double-blind, randomized, placebo-controlled study},
  url          = {http://dx.doi.org/10.1213/ane.0b013e31816b94c9},
  volume       = {107},
  year         = {2008},
}

Chicago
Aasvang, E., J. Hansen, J. Malmstrom, T. Asmussen, D. Gennevois, Michel Struys, and H. Kehlet. 2008. “The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: a Double-blind, Randomized, Placebo-controlled Study.” Anesthesia and Analgesia 107 (1): 282–291.
APA
Aasvang, E., Hansen, J., Malmstrom, J., Asmussen, T., Gennevois, D., Struys, M., & Kehlet, H. (2008). The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: a double-blind, randomized, placebo-controlled study. Anesthesia and Analgesia, 107(1), 282–291.
Vancouver
1.
Aasvang E, Hansen J, Malmstrom J, Asmussen T, Gennevois D, Struys M, et al. The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: a double-blind, randomized, placebo-controlled study. Anesthesia and Analgesia. 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USA: LIPPINCOTT WILLIAMS & WILKINS,; 2008;107(1):282–91.
MLA
Aasvang, E., J. Hansen, J. Malmstrom, et al. “The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: a Double-blind, Randomized, Placebo-controlled Study.” Anesthesia and Analgesia 107.1 (2008): 282–291. Print.