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

NCT00487084 | Completed Results

• 1 other identifier: 0524-021
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor; Analgesia, Epidural

Keywords

analgesia; tubal ligation; chloroprocaine

Outcome Measures

Primary Outcomes (2)

• Duration of Continuing Analgesia

  Time to first request for supplemental analgesia

  48 hours

• Supplemental Analgesia in First 90 Minutes

  Participants requesting supplemental analgesia in the first 90 minutes following study drug

  90 min

Secondary Outcomes (2)

• Verbal Rating Score (0 to 10) for Pain (VRPS)

  At recovery room entry

• Supplemental Analgesia in First 48 Hours

  48 hours

Study Arms (3)

morphine - 2CP-saline (MCS)

EXPERIMENTAL

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

Drug: Morphine-CP-saline (MCS)

saline-2CP-morphine (SCM)

EXPERIMENTAL

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

Drug: saline-2CP-morphine (SCM)

saline-lidocaine-morphine (SLM)

ACTIVE COMPARATOR

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

Drug: saline-lidocaine-morphine (SLM)

Interventions

Morphine-CP-saline (MCS) DRUG

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

morphine - 2CP-saline (MCS)

saline-2CP-morphine (SCM) DRUG

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

saline-2CP-morphine (SCM)

saline-lidocaine-morphine (SLM) DRUG

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

saline-lidocaine-morphine (SLM)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• 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.

  PMID: 1854026 BACKGROUND

• 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.

  PMID: 9241341 BACKGROUND

• 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.

  PMID: 2173443 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

• Title: Cynthia A. Wong,M.D.
• Organization: Northwestern University

c-wong2@northwestern.edu

630-472-3555

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 15, 2007
• Study Start: August 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 14, 2014
• Results First Posted: April 18, 2011

Record last verified: 2014-03

Locations

US (1)