Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia
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ClinicalTrials.gov Identifier: NCT00487084 |
Recruitment Status :
Completed
First Posted : June 15, 2007
Results First Posted : April 18, 2011
Last Update Posted : April 14, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Labor Analgesia, Epidural | Drug: Morphine-CP-saline (MCS) Drug: saline-2CP-morphine (SCM) Drug: saline-lidocaine-morphine (SLM) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 136 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Interaction Between Epidural 2-chloroprocaine and Epidural Morphine: Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: morphine - 2CP-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
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Drug: Morphine-CP-saline (MCS)
3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision |
Experimental: saline-2CP-morphine (SCM)
saline will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level;morphine will be administered at skin incision
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Drug: saline-2CP-morphine (SCM)
6ml of saline will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 3mg of preservative free morphine will be administered at skin incision |
Active Comparator: saline-lidocaine-morphine (SLM)
Saline will be administered 30 min prior to epidural anesthesia; lidocaine will be used to achieve a T4 level; morphine will be administered at skin incision
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Drug: saline-lidocaine-morphine (SLM)
3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 2% lidocaine with epinephrine 1:200,000 will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision |
- Duration of Continuing Analgesia [ Time Frame: 48 hours ]Time to first request for supplemental analgesia
- Supplemental Analgesia in First 90 Minutes [ Time Frame: 90 min ]Participants requesting supplemental analgesia in the first 90 minutes following study drug
- Verbal Rating Score (0 to 10) for Pain (VRPS) [ Time Frame: At recovery room entry ]Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable
- Supplemental Analgesia in First 48 Hours [ Time Frame: 48 hours ]Participants requesting supplemental analgesia in first 48 hours

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All patients with an epidural catheter in situ for labor analgesia, status post a vaginal delivery, and scheduled for a postpartum tubal ligation under epidural anesthesia will be eligible
Exclusion Criteria:
- Allergy/hypersensitivity to morphine
- Allergy/hypersensitivity to ester-linked local anesthetics or para-amino benzoic acid (PABA)
- Body Mass Index >40 kg/m2
- Patients using chronic opioids
- History of obstructive sleep apnea
- Any contraindication to epidural anesthesia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487084
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
Responsible Party: | Cynthia Wong, Professor of Anesthesiology, Northwestern University |
ClinicalTrials.gov Identifier: | NCT00487084 |
Other Study ID Numbers: |
0524-021 |
First Posted: | June 15, 2007 Key Record Dates |
Results First Posted: | April 18, 2011 |
Last Update Posted: | April 14, 2014 |
Last Verified: | March 2014 |
analgesia tubal ligation chloroprocaine |
Agnosia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Lidocaine Morphine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Analgesics |