Intracutaneous Sterile Water Injections

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01513447
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Intracutaneous injections	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Intracutaneous Sterile Water Injection as an Adjunct to Neuraxial Labor Analgesia: A Randomized Controlled Trial
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Breakthrough Back Labor Pain [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.

Secondary Outcome Measures

1. Total Local Anesthetic Consumption [24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Cynthia Wong, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bengtsson J, Worning AM, Gertz J, Struckmann J, Bonnesen T, Palludan H, Olsen PR, Frimodt-Møller 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. Danish.
• Cervero F, Tattersall JE. Somatic and visceral sensory integration in the thoracic spinal cord. Prog Brain Res. 1986;67:189-205.
• 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.
• 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. Review.
• 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. Review.
• Mårtensson 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.
• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review.
• 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. French.
• Reynolds JL. Intracutaneous sterile water for back pain in labour. Can Fam Physician. 1994 Oct;40:1785-8, 1791-2.
• 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.

• Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01513447
• Other Study ID Numbers: STU00057039
• First Posted: Jan 20, 2012
• Last Update Posted: Mar 2, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Cynthia Wong, Professor of Anesthesiology, Northwestern University: sterile water injections; back labor
• Additional relevant MeSH terms: Infertility; Labor Pain

Study Results

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 Detail	Delivery of infant in less than 90 minutes from recruitment.

Arm/Group Title	Sterile Water Injection	Normal Saline Injection
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	3	5
COMPLETED	3	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sterile Water Injection	Normal Saline Injection	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	3	5	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (10)	31 (4)	31 (7)
Sex: Female, Male (Count of Participants)
Female	3 100%	5 100%	8 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	5 100%	8 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Breakthrough Back Labor Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sterile Water Injection	Normal Saline Injection
Arm/Group Description	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.	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.
Measure Participants	3	5
Number [participants]	0 0%	2 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sterile Water Injection, Normal Saline Injection
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sterile Water Injection	Normal Saline Injection
Arm/Group Description	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.	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.
Measure Participants	3	5
Mean (Standard Deviation) [milliliters]	190 (104)	234 (60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sterile Water Injection, Normal Saline Injection
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	102
	Confidence Interval	(2-Sided) 95%; -230 to 171
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events were collected from intervention until delivery of infant, for up to 24 hours
Arm/Group Title	Sterile Water Injection		Normal Saline Injection
Arm/Group Description	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.		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.
All Cause Mortality
	Sterile Water Injection		Normal Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sterile Water Injection		Normal Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Sterile Water Injection		Normal Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.