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Comparison of Loss of Resistance Techniques

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Completed
Phase 2

Conditions

Pain Relief

Treatments

Procedure: Air
Procedure: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00638274
Air versus Saline

Details and patient eligibility

About

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.

Full 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.

Enrollment

356 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

356 participants in 2 patient groups

Air
Active Comparator group
Description:
Air 3 ml used to identify epidural space
Treatment:
Procedure: Air
Saline
Active Comparator group
Description:
Saline 3 ml used to identify epidural space
Treatment:
Procedure: Saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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