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Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain.
Reg Anesth Pain Med. 2000 May-Jun; 25(3):274-8.RA

Abstract

BACKGROUND AND OBJECTIVES

Voltage-sensitive calcium channel conductance is essential for the nervous system to signal a painful event. However, intrathecal administration of L-type calcium channel blockers does not provide analgesia. The present investigation was designed to assess the safety and analgesic efficacy of ziconotide, a new N-type calcium channel blocker, when administered intrathecally to patients with acute postoperative pain.

METHODS

This randomized, double-blind, pilot study included patients undergoing elective total abdominal hysterectomy, radical prostatectomy, or total hip replacement. After intrathecal injection of local anesthetic and before surgical incision, a continuous intrathecal infusion of either placebo or 1 of 2 doses of ziconotide (0.7 microg/h or 7.0 microg/h) was started and continued for 48 to 72 hours postoperatively. Primary and secondary efficacy variables were the mean daily patient controlled analgesia (PCA) morphine equivalent consumption and visual analog pain intensity (VASPI) scores, respectively.

RESULTS

Thirty patients received study drug; 26 were evaluable for efficacy. Mean daily PCA morphine equivalent consumption was less in patients receiving ziconotide than in placebo-treated patients, and the difference was statistically significant between 24 and 48 hours (P = .040). VASPI scores during the first 8 hours postoperatively were markedly lower in ziconotide-treated than in placebo-treated patients. In 4 of 6 patients receiving the high-dose of ziconotide (7 microg/h), adverse events, such as dizziness, blurred vision, nystagmus, and sedation contributed to study drug being discontinued after 24 hours. After ziconotide discontinuation, these symptoms resolved.

CONCLUSIONS

Ziconotide showed analgesic activity, as shown by decreased PCA morphine equivalent consumption and lower VASPI scores. Because of a favorable trend of decreased morphine consumption with an acceptable side-effect profile in the low-dose ziconotide group, 0.7 microg/h may be closer to the ideal dose than 7 microg/h. Large-scale studies are required to clarify this issue.

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Authors+Show Affiliations

Atanassoff PG
Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06520-8051, USA. peter.atanassoff@yale.edu
Hartmannsgruber MW
No affiliation info available
Thrasher J
No affiliation info available
Wermeling D
No affiliation info available
Longton W
No affiliation info available
Gaeta R
No affiliation info available
Singh T
No affiliation info available
Mayo M
No affiliation info available
McGuire D
No affiliation info available
Luther RR
No affiliation info available

MeSH

Acute DiseaseAdultAgedAged, 80 and overAnalgesia, Patient-ControlledAnalgesics, OpioidArthroplasty, Replacement, HipCalcium Channel BlockersCalcium Channels, N-TypeDouble-Blind MethodFemaleHumansInjections, SpinalMaleMiddle AgedMorphinePain MeasurementPain, PostoperativePilot Projectsomega-Conotoxins

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10834782

Citation

Atanassoff, P G., et al. "Ziconotide, a New N-type Calcium Channel Blocker, Administered Intrathecally for Acute Postoperative Pain." Regional Anesthesia and Pain Medicine, vol. 25, no. 3, 2000, pp. 274-8.
Atanassoff PG, Hartmannsgruber MW, Thrasher J, et al. Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain. Reg Anesth Pain Med. 2000;25(3):274-8.
Atanassoff, P. G., Hartmannsgruber, M. W., Thrasher, J., Wermeling, D., Longton, W., Gaeta, R., Singh, T., Mayo, M., McGuire, D., & Luther, R. R. (2000). Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain. Regional Anesthesia and Pain Medicine, 25(3), 274-8.
Atanassoff PG, et al. Ziconotide, a New N-type Calcium Channel Blocker, Administered Intrathecally for Acute Postoperative Pain. Reg Anesth Pain Med. 2000 May-Jun;25(3):274-8. PubMed PMID: 10834782.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain. AU - Atanassoff,P G, AU - Hartmannsgruber,M W, AU - Thrasher,J, AU - Wermeling,D, AU - Longton,W, AU - Gaeta,R, AU - Singh,T, AU - Mayo,M, AU - McGuire,D, AU - Luther,R R, PY - 2000/6/2/pubmed PY - 2000/9/23/medline PY - 2000/6/2/entrez SP - 274 EP - 8 JF - Regional anesthesia and pain medicine JO - Reg Anesth Pain Med VL - 25 IS - 3 N2 - BACKGROUND AND OBJECTIVES: Voltage-sensitive calcium channel conductance is essential for the nervous system to signal a painful event. However, intrathecal administration of L-type calcium channel blockers does not provide analgesia. The present investigation was designed to assess the safety and analgesic efficacy of ziconotide, a new N-type calcium channel blocker, when administered intrathecally to patients with acute postoperative pain. METHODS: This randomized, double-blind, pilot study included patients undergoing elective total abdominal hysterectomy, radical prostatectomy, or total hip replacement. After intrathecal injection of local anesthetic and before surgical incision, a continuous intrathecal infusion of either placebo or 1 of 2 doses of ziconotide (0.7 microg/h or 7.0 microg/h) was started and continued for 48 to 72 hours postoperatively. Primary and secondary efficacy variables were the mean daily patient controlled analgesia (PCA) morphine equivalent consumption and visual analog pain intensity (VASPI) scores, respectively. RESULTS: Thirty patients received study drug; 26 were evaluable for efficacy. Mean daily PCA morphine equivalent consumption was less in patients receiving ziconotide than in placebo-treated patients, and the difference was statistically significant between 24 and 48 hours (P = .040). VASPI scores during the first 8 hours postoperatively were markedly lower in ziconotide-treated than in placebo-treated patients. In 4 of 6 patients receiving the high-dose of ziconotide (7 microg/h), adverse events, such as dizziness, blurred vision, nystagmus, and sedation contributed to study drug being discontinued after 24 hours. After ziconotide discontinuation, these symptoms resolved. CONCLUSIONS: Ziconotide showed analgesic activity, as shown by decreased PCA morphine equivalent consumption and lower VASPI scores. Because of a favorable trend of decreased morphine consumption with an acceptable side-effect profile in the low-dose ziconotide group, 0.7 microg/h may be closer to the ideal dose than 7 microg/h. Large-scale studies are required to clarify this issue. SN - 1098-7339 UR - https://www.unboundmedicine.com/medline/citation/10834782/Ziconotide_a_new_N_type_calcium_channel_blocker_administered_intrathecally_for_acute_postoperative_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1098-7339(00)90010-5 DB - PRIME DP - Unbound Medicine ER -