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

Primary Purpose

Labor, Analgesia, Epidural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine-CP-saline (MCS)
saline-2CP-morphine (SCM)
saline-lidocaine-morphine (SLM)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor focused on measuring analgesia, tubal ligation, chloroprocaine

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

morphine - 2CP-saline (MCS)

saline-2CP-morphine (SCM)

saline-lidocaine-morphine (SLM)

Arm Description

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 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

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

Outcomes

Primary Outcome Measures

Duration of Continuing Analgesia
Time to first request for supplemental analgesia
Supplemental Analgesia in First 90 Minutes
Participants requesting supplemental analgesia in the first 90 minutes following study drug

Secondary Outcome Measures

Verbal Rating Score (0 to 10) for Pain (VRPS)
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
Participants requesting supplemental analgesia in first 48 hours

Full Information

First Posted
June 13, 2007
Last Updated
March 17, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00487084
Brief Title
Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia
Official Title
Interaction Between Epidural 2-chloroprocaine and Epidural Morphine: Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.
Detailed Description
Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of three groups for pain control. The groups are epidural 1) epidural morphine-chloroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine. Groups 1 and 3 will receive morphine 30 minutes prior to local anesthetic dosing followed by saline placebo after local dosing. Group 2 will receive placebo 30 minutes prior to local anesthetic dosing followed by epidural morphine. Pain scores and supplemental analgesic requirements will be evaluated 30 minutes, 1hr, 2hr, 4hr and every 4 hrs for the first 24hrs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Analgesia, Epidural
Keywords
analgesia, tubal ligation, chloroprocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morphine - 2CP-saline (MCS)
Arm Type
Experimental
Arm Description
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
Arm Title
saline-2CP-morphine (SCM)
Arm Type
Experimental
Arm Description
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
Arm Title
saline-lidocaine-morphine (SLM)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Morphine-CP-saline (MCS)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
saline-2CP-morphine (SCM)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
saline-lidocaine-morphine (SLM)
Intervention Description
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
Primary Outcome Measure Information:
Title
Duration of Continuing Analgesia
Description
Time to first request for supplemental analgesia
Time Frame
48 hours
Title
Supplemental Analgesia in First 90 Minutes
Description
Participants requesting supplemental analgesia in the first 90 minutes following study drug
Time Frame
90 min
Secondary Outcome Measure Information:
Title
Verbal Rating Score (0 to 10) for Pain (VRPS)
Description
Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable
Time Frame
At recovery room entry
Title
Supplemental Analgesia in First 48 Hours
Description
Participants requesting supplemental analgesia in first 48 hours
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia A Wong, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1854026
Citation
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. doi: 10.1213/00000539-199108000-00003.
Results Reference
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PubMed Identifier
9241341
Citation
Karambelkar DJ, Ramanathan S. 2-Chloroprocaine antagonism of epidural morphine analgesia. Acta Anaesthesiol Scand. 1997 Jun;41(6):774-8. doi: 10.1111/j.1399-6576.1997.tb04782.x.
Results Reference
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PubMed Identifier
2173443
Citation
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. doi: 10.1097/00000542-199011000-00011.
Results Reference
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Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

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