Comparison of Loss of Resistance Techniques

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00638274
• Collaborator: (none)
• Enrollment: 356
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

Condition or Disease	Intervention/Treatment	Phase
Pain Relief	Procedure: Air; Procedure: Saline	Phase 2

Detailed Description

When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.

The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Air Air 3 ml used to identify epidural space	Procedure: Air; 3 mls used for identifying epidural space
Active Comparator: Saline Saline 3 ml used to identify epidural space	Procedure: Saline; 3 mls of saline used to identify epidural space

Outcome Measures

Primary Outcome Measures

1. Success of Spinal Labor Analgesia From Combined Spinal Epidural [24 hours]

   Number of participants that had successful spinal labor analgesia in each group.

Secondary Outcome Measures

1. Number of Participants With Failed Epidural Catheters [24 hours]

   Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant females weighing less than or equal to 250 lbs

• Request for neuraxial labor analgesia

Exclusion Criteria:

• ASA physical status greater than II

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 11, 2006

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00638274
• Other Study ID Numbers: Air versus Saline
• First Posted: Mar 19, 2008
• Last Update Posted: Nov 9, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: Quality of pain relief with 2 different methods of identifying epidural space

Study Results

Participant Flow

Arm/Group Title	1-AIR	2-SALINE
Arm/Group Description	Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space	Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space
Period Title: Overall Study
STARTED	179	177
COMPLETED	173	172
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	1-AIR	2-SALINE	Total
Arm/Group Description	Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space	Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space	Total of all reporting groups
Overall Participants	173	172	345
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	173 100%	172 100%	345 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	173 100%	172 100%	345 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	173 100%	172 100%	345 100%

Outcome Measures

1. Primary Outcome

Title	Success of Spinal Labor Analgesia From Combined Spinal Epidural
Description	Number of participants that had successful spinal labor analgesia in each group.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1-AIR	2-SALINE
Arm/Group Description	Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space	Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space
Measure Participants	173	172
Count of Participants [Participants]	163 94.2%	161 93.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1-AIR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	2-SALINE
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants With Failed Epidural Catheters
Description	Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1-AIR	2-SALINE
Arm/Group Description	Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space	Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space
Measure Participants	173	172
Count of Participants [Participants]	5 2.9%	9 5.2%

Adverse Events

Time Frame	Adverse event data were collected from the time the epidural catheter was placed until the time of delivery, usually less than 24 hours
Arm/Group Title	1-AIR		2-SALINE
Arm/Group Description	Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space		Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space
All Cause Mortality
	1-AIR		2-SALINE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/173 (0%)		0/172 (0%)
Serious Adverse Events
	1-AIR		2-SALINE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/173 (0%)		0/172 (0%)
Other (Not Including Serious) Adverse Events
	1-AIR		2-SALINE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/173 (0%)		0/172 (0%)

Limitations/Caveats

[Not Specified]

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.