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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At recovery room entry |
| Supplemental Analgesia in First 48 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Wong, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1854026 | Background | 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. | |
| 9241341 | 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. |
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Excluded from randomization (n=37), 26 refused to participate, 11 did not meet exclusion criteria
136 subjects approached and assessed for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Saline - Lidocaine - Morphine (SLM) | Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Saline-2 Chloroprocaine - Morphine (SCM) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Continuing Analgesia | Time to first request for supplemental analgesia | All participants receiving the intervention were analyzed | Posted | Median | 95% Confidence Interval | hours | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia A. Wong,M.D. | Northwestern University | 630-472-3555 | c-wong2@northwestern.edu |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| 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-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 |
|
Participants requesting supplemental analgesia in first 48 hours
| 48 hours |
| 2173443 | 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. |
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 |
| BG002 | Saline - Lidocaine - Morphine (SLM) | Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Saline - Lidocaine - Morphine (SLM) | Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision. |
|
|
|
| Secondary | 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 | Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable | Posted | Median | Inter-Quartile Range | Scores on a scale | At recovery room entry |
|
|
|
|
| Primary | Supplemental Analgesia in First 90 Minutes | Participants requesting supplemental analgesia in the first 90 minutes following study drug | Posted | Number | participants | 90 min |
|
|
|
|
| Secondary | Supplemental Analgesia in First 48 Hours | Participants requesting supplemental analgesia in first 48 hours | Posted | Number | Participants | 48 hours |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 30 | 0 | 30 |
| EG002 | Saline - Lidocaine - Morphine (SLM) | Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision. | 0 | 28 | 0 | 28 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |