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Intracutaneous Sterile Water Injections

Intracutaneous Sterile Water Injection as an Adjunct to Neuraxial Labor Analgesia: A Randomized Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01513447
Enrollment
8
Registered
2012-01-20
Start date
2011-12-31
Completion date
2013-12-31
Last updated
2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

sterile water injections, back labor

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 anesthesia/analgesia 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 (e.g., 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. 0.1 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 0.1 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 0.4 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.

Interventions

DRUGIntracutaneous injections

Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* multiparous women * spontaneous labor * at least 18 years of age * presenting for vaginal delivery with cervical dilation of 4 centimeters or less

Exclusion criteria

* nulliparous * less than 18 years old * contraindication to placement of neuraxial anesthetic * skin infection in area to be injected * medical therapies considered to result in tolerance to opioids * history of chronic pain (requiring regular medical follow-up with pain specialists) * recent use of opioid analgesics (within the year preceding pregnancy)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Breakthrough Back Labor Painwithin 24 hoursIt is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.

Secondary

MeasureTime frameDescription
Total Local Anesthetic Consumption24 hoursIt is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.

Countries

United States

Participant flow

Recruitment details

Recruitment began 4/17/2012, ended 10/26/2012. Recruitment stopped due to low number of subjects meeting study criteria for entry.

Pre-assignment details

Delivery of infant in less than 90 minutes from recruitment.

Participants by arm

ArmCount
Sterile Water Injection
In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point. Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.
3
Normal Saline Injection
In the sitting position, study subjects will receive a total of 0.4 mL of study drug via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point. Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.
5
Total8

Baseline characteristics

CharacteristicSterile Water InjectionNormal Saline InjectionTotal
Age, Continuous32 years
STANDARD_DEVIATION 10
31 years
STANDARD_DEVIATION 4
31 years
STANDARD_DEVIATION 7
Region of Enrollment
United States
3 participants5 participants8 participants
Sex: Female, Male
Female
3 Participants5 Participants8 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 30 / 5
serious
Total, serious adverse events
0 / 30 / 5

Outcome results

Primary

Number of Participants With Breakthrough Back Labor Pain

It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.

Time frame: within 24 hours

ArmMeasureValue (NUMBER)
Sterile Water InjectionNumber of Participants With Breakthrough Back Labor Pain0 participants
Normal Saline InjectionNumber of Participants With Breakthrough Back Labor Pain2 participants
p-value: 0.67Fisher Exact
Secondary

Total Local Anesthetic Consumption

It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Sterile Water InjectionTotal Local Anesthetic Consumption190 millilitersStandard Deviation 104
Normal Saline InjectionTotal Local Anesthetic Consumption234 millilitersStandard Deviation 60
p-value: 0.2995% CI: [-230, 171]Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026