Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

This study has been completed.

Study NCT00487084 Information provided by Northwestern University

First Received on June 13, 2007. Last Updated on May 9, 2011 History of Changes

Results First Received: February 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Labor Analgesia, Epidural
Interventions:	Drug: Morphine-CP-saline (MCS) Drug: saline-2CP-morphine (SCM) Drug: saline-lidocaine-morphine (SLM)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
136 subjects approached and assessed for eligibility

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Excluded from randomization (n=37), 26 refused to participate, 11 did not meet exclusion criteria

Reporting Groups

	Description
Morphine - 2 Chloroprocaine - Saline (MCS)	morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
Saline-2 Chloroprocaine - Morphine (SCM)	saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
Saline - Lidocaine - Morphine (SLM)	Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.

Participant Flow: Overall Study

	Morphine - 2 Chloroprocaine - Saline (MCS)	Saline-2 Chloroprocaine - Morphine (SCM)	Saline - Lidocaine - Morphine (SLM)
STARTED	33	33	33
COMPLETED	29	30	28
NOT COMPLETED	4	3	5
Did not receive intervention	4	3	5

Baseline Characteristics

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Reporting Groups

	Description
Morphine - 2 Chloroprocaine - Saline (MCS)	morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
Saline-2 Chloroprocaine - Morphine (SCM)	saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
Saline - Lidocaine - Morphine (SLM)	Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.

Baseline Measures

	Morphine - 2 Chloroprocaine - Saline (MCS)	Saline-2 Chloroprocaine - Morphine (SCM)	Saline - Lidocaine - Morphine (SLM)	Total
Number of Participants [units: participants]	33	33	33	99
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	33	33	33	99
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	33 ± 4	31 ± 5	29 ± 4	30 ± 4
Gender [units: participants]
Female	33	33	33	99
Male	0	0	0	0
Region of Enrollment [units: participants]
United States	33	33	33	99

Outcome Measures

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1. Primary:

Duration of Continuing Analgesia [ Time Frame: 48 hours ]

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2. Primary:

Supplemental Analgesia in First 90 Minutes [ Time Frame: 90 min ]

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3. Secondary:

Verbal Rating Score (0 to 10) for Pain (VRPS) [ Time Frame: At recovery room entry ]

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4. Secondary:

Supplemental Analgesia in First 48 Hours [ Time Frame: 48 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We used a single 30-minute interval between morphine and 2-chloroprocaine administration and additional investigation is warranted to determine the optimum interval for administration.

Results Point of Contact:

Name/Title: Cynthia A. Wong,M.D.
Organization: Northwestern University
phone: 630-472-3555
e-mail: c-wong2@northwestern.edu

Publications:

Eisenach JC, Schlairet TJ, Dobson CE 2nd, Hood DH. Effect of prior anesthetic solution on epidural morphine analgesia. Anesth Analg. 1991 Aug;73(2):119-23.

Karambelkar DJ, Ramanathan S. 2-Chloroprocaine antagonism of epidural morphine analgesia. Acta Anaesthesiol Scand. 1997 Jun;41(6):774-8.

Camann WR, Hartigan PM, Gilbertson LI, Johnson MD, Datta S. Chloroprocaine antagonism of epidural opioid analgesia: a receptor-specific phenomenon? Anesthesiology. 1990 Nov;73(5):860-3.

Responsible Party:	Cynthia A. Wong, M.D., Northwestern University
ClinicalTrials.gov Identifier:	NCT00487084 History of Changes
Other Study ID Numbers:	0524-021
Study First Received:	June 13, 2007
Results First Received:	February 9, 2011
Last Updated:	May 9, 2011
Health Authority:	United States: Institutional Review Board