PMID- 10834782
OWN - NLM
STAT- MEDLINE
DCOM- 20000915
LR  - 20191104
IS  - 1098-7339 (Print)
IS  - 1098-7339 (Linking)
VI  - 25
IP  - 3
DP  - 2000 May-Jun
TI  - Ziconotide, a new N-type calcium channel blocker, administered intrathecally for 
      acute postoperative pain.
PG  - 274-8
AB  - 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.
FAU - Atanassoff, P G
AU  - Atanassoff PG
AD  - Department of Anesthesiology, Yale University School of Medicine, New Haven, 
      Connecticut 06520-8051, USA. peter.atanassoff@yale.edu
FAU - Hartmannsgruber, M W
AU  - Hartmannsgruber MW
FAU - Thrasher, J
AU  - Thrasher J
FAU - Wermeling, D
AU  - Wermeling D
FAU - Longton, W
AU  - Longton W
FAU - Gaeta, R
AU  - Gaeta R
FAU - Singh, T
AU  - Singh T
FAU - Mayo, M
AU  - Mayo M
FAU - McGuire, D
AU  - McGuire D
FAU - Luther, R R
AU  - Luther RR
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Reg Anesth Pain Med
JT  - Regional anesthesia and pain medicine
JID - 9804508
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Calcium Channel Blockers)
RN  - 0 (Calcium Channels, N-Type)
RN  - 0 (omega-Conotoxins)
RN  - 76I7G6D29C (Morphine)
RN  - 7I64C51O16 (ziconotide)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesia, Patient-Controlled
MH  - Analgesics, Opioid/administration & dosage/therapeutic use
MH  - Arthroplasty, Replacement, Hip
MH  - Calcium Channel Blockers/administration & dosage/adverse effects/*therapeutic use
MH  - Calcium Channels, N-Type/drug effects/*metabolism
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Spinal
MH  - Male
MH  - Middle Aged
MH  - Morphine/administration & dosage/therapeutic use
MH  - Pain Measurement
MH  - Pain, Postoperative/*drug therapy
MH  - Pilot Projects
MH  - omega-Conotoxins/administration & dosage/adverse effects/*therapeutic use
EDAT- 2000/06/02 09:00
MHDA- 2000/09/23 11:01
CRDT- 2000/06/02 09:00
PHST- 2000/06/02 09:00 [pubmed]
PHST- 2000/09/23 11:01 [medline]
PHST- 2000/06/02 09:00 [entrez]
AID - S1098-7339(00)90010-5 [pii]
AID - 10.1016/s1098-7339(00)90010-5 [doi]
PST - ppublish
SO  - Reg Anesth Pain Med. 2000 May-Jun;25(3):274-8. doi: 
      10.1016/s1098-7339(00)90010-5.