Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01513447
Status:
TERMINATED
Last Update Posted:
2015-03-02
First Post:
2012-01-16
Brief Title:
Intracutaneous Sterile Water Injections
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Intracutaneous Sterile Water Injection as an Adjunct to Neuraxial Labor Analgesia A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low qualified candidate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For most women the most significant pain they will experience is the pain associated with childbirth Up to one-third of women experience back labor this typically occurs when the fetus assumes varying degrees of malposition especially the occiput posterior position and causes additional constant pressure against the maternal spine and pelvis Back labor presents as constant pain that occurs even between contractions It is often difficult to manage by the patient the obstetrician and the anesthesiologist and may increase the rate of instrumental and caesarian delivery
Epidural anesthesiaanalgesia is the most common and effective intervention used to help women cope with labor pain Dilute concentrations of local anesthetic and opioid provide complete analgesia for most women Some women however have breakthrough pain often due to back labor and require more concentrated drug solutions This increases the side effects associated with these drugs eg hypotension pruritus motor block thus treatment of this pain poses a challenge for the anesthesiologist and the obstetrician
Sterile water injections SWI are a simple and well-established method of managing labor pain among midwives This intervention was first used to alleviate pain associated with kidney stones and was introduced to obstetrics in the 1970s Using a syringe small amounts of sterile water is deposited subcutaneously near the sacral area The sterile water causes osmotic and mechanical irritation resulting in a brief 15-30 second and significant stinging sensation The onset of pain relief follows almost immediately and may last for up to two hours The procedure can be repeated a number of times
Sterile water for pain management is most often administered using four intracutaneous injections two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm medial to the original two injection sites 01 mL of sterile water is injected between the dermal layers to raise a small bleb on the skin surface at each of the four sites In labor the injections are administered sequentially during a uterine contraction with the series of four injections performed two at a time completed within 20-30 seconds
The investigators hypothesize that the use of sterile water injections in women with neuraxial analgesia with breakthrough pain will result in decreased local anesthetic requirements and increase patient satisfaction
Epidural anesthesiaanalgesia is the most common and effective intervention used to help women cope with labor pain Dilute concentrations of local anesthetic and opioid provide complete analgesia for most women Some women however have breakthrough pain often due to back labor and require more concentrated drug solutions This increases the side effects associated with these drugs eg hypotension pruritus motor block thus treatment of this pain poses a challenge for the anesthesiologist and the obstetrician
Sterile water injections SWI are a simple and well-established method of managing labor pain among midwives This intervention was first used to alleviate pain associated with kidney stones and was introduced to obstetrics in the 1970s Using a syringe small amounts of sterile water is deposited subcutaneously near the sacral area The sterile water causes osmotic and mechanical irritation resulting in a brief 15-30 second and significant stinging sensation The onset of pain relief follows almost immediately and may last for up to two hours The procedure can be repeated a number of times
Sterile water for pain management is most often administered using four intracutaneous injections two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm medial to the original two injection sites 01 mL of sterile water is injected between the dermal layers to raise a small bleb on the skin surface at each of the four sites In labor the injections are administered sequentially during a uterine contraction with the series of four injections performed two at a time completed within 20-30 seconds
The investigators hypothesize that the use of sterile water injections in women with neuraxial analgesia with breakthrough pain will result in decreased local anesthetic requirements and increase patient satisfaction
Detailed Description:
Since it is assumed that the neuraxial anesthetic is placed prior to transition to active phase of labor the patient will receive the intervention when they report breakthrough pain Prior to administration of the intervention the adequacy of the existing neuraxial anesthetic will be verified as bilateral decreased discrimination to cold from T8 to the sacrum Four tuberculin syringes each containing 01 mL of the assigned solution labeled study drug will be prepared Patients allocated to the study group will receive sterile water and those allocated to the control group will receive sterile normal saline solution
The area to be injected will be prepared with chlorhexidine wipes to ensure sterility In the sitting position study subjects will receive a total of 04 mL of study drug via four injections bilateral injections at the posterior superior iliac spine on and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point
Patients will be asked to rate their overall labor pain using a 0-100 mm visual analog scale VAS for pain prior to study drug administration and every 30 minutes until commencement of pushing They will also be asked to specifically rate low back pain with the VAS Analgesia administration data from the time of study drug injection including maintenance epidural solution volume time of first patient controlled epidural analgesia PCEA bolus request number of PCEA bolus requests and delivered doses total PCEA bupivacaine dose time to first request for manual rebolus number of manual bolus doses manual bolus bupivacaine dose total bupivacaine dose and total fentanyl dose
Additional recorded data will include maternal age height weight cervical dilation at initiation of neuraxial analgesia and at study drug administration duration of labor initiation of analgesia to delivery maximum oxytocin infusion rate during labor and mode of delivery A total labor pain score will be assessed approximately 60 minute after delivery as well as satisfaction with labor analgesia using a 100-mm VAS
The area to be injected will be prepared with chlorhexidine wipes to ensure sterility In the sitting position study subjects will receive a total of 04 mL of study drug via four injections bilateral injections at the posterior superior iliac spine on and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point
Patients will be asked to rate their overall labor pain using a 0-100 mm visual analog scale VAS for pain prior to study drug administration and every 30 minutes until commencement of pushing They will also be asked to specifically rate low back pain with the VAS Analgesia administration data from the time of study drug injection including maintenance epidural solution volume time of first patient controlled epidural analgesia PCEA bolus request number of PCEA bolus requests and delivered doses total PCEA bupivacaine dose time to first request for manual rebolus number of manual bolus doses manual bolus bupivacaine dose total bupivacaine dose and total fentanyl dose
Additional recorded data will include maternal age height weight cervical dilation at initiation of neuraxial analgesia and at study drug administration duration of labor initiation of analgesia to delivery maximum oxytocin infusion rate during labor and mode of delivery A total labor pain score will be assessed approximately 60 minute after delivery as well as satisfaction with labor analgesia using a 100-mm VAS
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