Intracutaneous Sterile Water Injections

February 23, 2015 updated by: Cynthia Wong, Northwestern University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Placebo Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Breakthrough Back Labor Pain
Time Frame: within 24 hours
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.
within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Local Anesthetic Consumption
Time Frame: 24 hours
It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Cynthia Wong, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00057039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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