Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572241
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural a Double-blinded Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuraxial analgesia has shown to be the gold standard for effective labor pain relief offering numerous benefits including enhanced pain control and maternal satisfaction The methods to achieve neuraxial analgesia include lumbar epidural LE and combined spinal epidural CSE While LE may not consistently provide optimal pain relief leading to frequent maternal requests for supplemental analgesics CSE presents a promising advancement This is due to the rapid onset of pain relief from intrathecal components complemented by the longer-lasting effects of epidural medications Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications Nonetheless some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient
The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal spinal component of CSE reduces the rate of breakthrough pain during labor
The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal spinal component of CSE reduces the rate of breakthrough pain during labor
Detailed Description:
The addition of morphine to a combination of bupivacaine and lipophilic opioids fentanyl for the spinal component of CSE for labor analgesia has been shown to increase the duration of analgesia A meta-analysis by Al-Kazwini and coworkers suggests a possible beneficial prolonging effect of adding morphine to spinal analgesia however the authors concluded that more adequately powered randomized controlled trials RCTs are required to determine the benefits and harms of intrathecal morphine ITM
This prolonged duration of action of ITM may reduce the need for frequent top-ups which could alleviate nursing and anesthesiologist workload and enhance maternal satisfaction An RCT conducted by Vasudevan and coworkers has concluded that the addition of 100 mcg ITM along with bupivacaine and fentanyl reduced the incidence of breakthrough pain in labor Another dose-finding study comparing 50 and 100 mcg of ITM as a component of CSE labor analgesia concluded that 100 mcg of ITM significantly lowers the local anesthetic consumption and shorter duration of the first stage of labor without any significant difference in adverse effects The RCT by Vasudevan et al had a small sample size enrolled mixed parity patients and utilized continuous infusion for labor analgesia maintenance
Hence the investigators plan to conduct adequately powered RCT enrolling only primigravidae patients which tend to have more prolonged labor than multiparous and programmed intermittent epidural bolus PIEB with patient-controlled epidural analgesia PCEA will be used which is a more contemporary labor maintenance technique
This prolonged duration of action of ITM may reduce the need for frequent top-ups which could alleviate nursing and anesthesiologist workload and enhance maternal satisfaction An RCT conducted by Vasudevan and coworkers has concluded that the addition of 100 mcg ITM along with bupivacaine and fentanyl reduced the incidence of breakthrough pain in labor Another dose-finding study comparing 50 and 100 mcg of ITM as a component of CSE labor analgesia concluded that 100 mcg of ITM significantly lowers the local anesthetic consumption and shorter duration of the first stage of labor without any significant difference in adverse effects The RCT by Vasudevan et al had a small sample size enrolled mixed parity patients and utilized continuous infusion for labor analgesia maintenance
Hence the investigators plan to conduct adequately powered RCT enrolling only primigravidae patients which tend to have more prolonged labor than multiparous and programmed intermittent epidural bolus PIEB with patient-controlled epidural analgesia PCEA will be used which is a more contemporary labor maintenance technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None