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Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space to continue to give pain relief medication. During a CSE, after injection of the medication in the CSF and before inserting the epidural catheter, if normal saline is injected into the epidural space, there may be an increase in pain relief and an increase in the level of numbness. This injection of saline in the epidural space to increase pain relief and numbness is termed epidural volume extension (EVE). The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia (pain relief) using CSE in pregnant laboring patients.
Regional analgesia (pain relief) for labor can be an epidural, a spinal or a combination of the two. Combined spinal-epidurals (CSE) are popular because of their rapid pain relief and high patient satisfaction. At the IWK Health Centre, many anesthesiologists routinely use this method of pain relief. It involves the injection of pain relief medication into the cerebral spinal fluid (CSF) and the insertion of an epidural catheter (slim plastic tube) in the epidural space to continue to give pain relief medication. The epidural space is located just outside the CSF. In order to insert the epidural catheter, some anesthesiologists inject 2-4 ml of saline in the epidural space to help the catheter go in. During a CSE, after injection of the medication in the CSF and before inserting the epidural catheter, if normal saline is injected into the epidural space, there may be an increase in pain relief and an increase in the level of numbness. This injection of saline in the epidural space to increase pain relief and numbness is termed epidural volume extension (EVE).
Thus far, studies on EVE have all been done in patients undergoing surgery with spinal anesthesia and not solely for analgesia. The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia (pain relief) using CSE. We will study 60 women requesting labor pain relief. Half these women will receive a CSE without EVE, which is the present standard of care. The other half will receive a CSE with 10 ml of saline for EVE before inserting the epidural catheter. We will then determine if there is a benefit for EVE by observing for a difference between the two groups with respect to the level of numbness, the amount and speed of pain relief and the intensity of leg weakness. We hypothesize that injecting 10 ml of saline for EVE using CSE may improve the amount and speed of pain relief while decreasing side effects such as leg weakness. If there were a benefit to EVE, this would be a simple and inexpensive method for improving pain relief in laboring women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Volume Extension | Experimental | CSE with 10 ml EVE |
|
| No Epidural Volume Extension | Active Comparator | CSE without EVE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSE with 10 ml EVE | Procedure | Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensory dermatome level | As determined by non-traumatic pinprick test | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia | As assessed by numeric rating scale (NRS) | 30 minutes |
| Motor block | Assessed using a modified Bromage scale | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Includes hypotension, pruritus, nausea, fetal distress, and local anesthetic toxicity related side effects | 30 minutes |
| Additional analgesia given | Either self-administered by the patient via PCEA (Patient Controlled Epidural Analgesia) button, or administered by an anesthesiologist |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Zaphiratos, MSc MD FRCPC | IWK Health Centre | Principal Investigator |
| Ronald B George, MD FRCPC | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's and Obstetric Anesthesia, IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27088994 | Derived | Zaphiratos V, George RB, Macaulay B, Bolleddula P, McKeen DM. Epidural Volume Extension During Combined Spinal-Epidural Labor Analgesia Does Not Increase Sensory Block. Anesth Analg. 2016 Sep;123(3):684-9. doi: 10.1213/ANE.0000000000001281. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| CSE without EVE | Procedure | Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE) |
|
| 30 minutes |