Intracutaneous Sterile Water Injections

NCT01513447 | Terminated Results

• 1 other identifier: STU00057039
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

sterile water injections; back labor

Outcome Measures

Primary Outcomes (1)

• 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.

  within 24 hours

Secondary Outcomes (1)

• Total Local Anesthetic Consumption

  24 hours

Study Arms (2)

Sterile Water Injection

ACTIVE COMPARATOR

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

Normal Saline Injection

PLACEBO COMPARATOR

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

Interventions

Intracutaneous injections DRUG

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.

Normal Saline Injection; Sterile Water Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

• Creehan PA. Pain relief and comfort measures in labor. In: Simpson KR, Creehan PA, editors. AWHONN's Perinatal Nursing, 3rd edn. Philadelphia, PA: Lippincott Williams & Wilkins; 2008. pp. 444-72.

  BACKGROUND

• Cervero F, Tattersall JE. Somatic and visceral sensory integration in the thoracic spinal cord. Prog Brain Res. 1986;67:189-205. doi: 10.1016/s0079-6123(08)62763-6. No abstract available.

  PMID: 3823471 BACKGROUND

• Bengtsson J, Worning AM, Gertz J, Struckmann J, Bonnesen T, Palludan H, Olsen PR, Frimodt-Moller C. [Pain due to urolithiasis treated by intracutaneous injection of sterile water. A clinically controlled double-blind study]. Ugeskr Laeger. 1981 Dec 14;143(51):3463-5. No abstract available. Danish.

  PMID: 7039061 BACKGROUND

• Odent M. [Letter: Lumbar reflexotherapy. Efficacy in the treatment of nephrotic colic and in obstretrical analgesia]. Nouv Presse Med. 1975 Jan 18;4(3):188. No abstract available. French.

  PMID: 1129076 BACKGROUND

• Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.

  PMID: 15295342 BACKGROUND

• Reynolds JL. Intracutaneous sterile water for back pain in labour. Can Fam Physician. 1994 Oct;40:1785-8, 1791-2.

  PMID: 7950471 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Martensson L, McSwiggin M, Mercer JS. US midwives' knowledge and use of sterile water injections for labor pain. J Midwifery Womens Health. 2008 Mar-Apr;53(2):115-22. doi: 10.1016/j.jmwh.2007.09.008.

  PMID: 18308260 BACKGROUND

• Hutton EK, Kasperink M, Rutten M, Reitsma A, Wainman B. Sterile water injection for labour pain: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2009 Aug;116(9):1158-66. doi: 10.1111/j.1471-0528.2009.02221.x. Epub 2009 May 14.

  PMID: 19459860 BACKGROUND

• Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.

  PMID: 21430035 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; Subjects recruitment unsuccessful because of low number of subjects that were eligible for study inclusion.

Results Point of Contact

• Title: Cynthia A. Wong, M.D.
• Organization: Northwestern University Feinberg School of Medicine

c-wong2@northwestern.edu

312-472-3585

Study Officials

• Cynthia Wong, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 2, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-02

Locations

US (1)