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

Northwestern University

Status: Completed

Conditions: Labor; Analgesia, Epidural

Treatments: Drug: saline-lidocaine-morphine (SLM); Drug: Morphine-CP-saline (MCS); Drug: saline-2CP-morphine (SCM)

Study type: Interventional

Funder types: Other

Identifiers

NCT00487084

0524-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 3 patient groups

morphine - 2CP-saline (MCS)

Experimental group

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

Treatment:

Drug: Morphine-CP-saline (MCS)

saline-2CP-morphine (SCM)

Experimental group

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

Treatment:

Drug: saline-2CP-morphine (SCM)

saline-lidocaine-morphine (SLM)

Active Comparator group

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

Treatment:

Drug: saline-lidocaine-morphine (SLM)