Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02340806
Other study ID # STU00100819
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date March 2017

Study information

Verified date November 2019
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.


Description:

Cervical dilation will be confirmed by a member of the obstetric team prior to epidural catheter placement as is routinely done at our institution. A baseline pain visual analog scale (VAS) score will be obtained using a 100-mm unmarked line with the end points labeled "no pain" and "worst pain imaginable.

Labor analgesia will be initiated using CSE analgesia with 25 mcg of intrathecal fentanyl. An epidural test dose will be performed as routine (1.5% lidocaine with epinephrine 1:200, 3 mL).

Labor analgesia will be maintained using timed-intermittent boluses of local anesthetic with PCEA using the CADD-Solis pump (Smiths Medical). An unblinded anesthesia research nurse will program the epidural pump and initiate the maintenance of labor analgesia.

Fifteen minutes following the intrathecal dose, a VAS score and a sensory level of analgesia will be obtained. The following information will be obtained hourly until complete cervical dilation (10 cm): VAS pain score, sensory level, a modified Bromage score (0 - no motor paralysis; 1 - inability to raise extended leg, but able to move knee and foot; 2 - inability to raise extended leg and to move knee, but able to move foot; 3 - inability to raise extended leg or to move knee and foot).

The time to the first request for supplemental analgesia will be recorded on the study data sheet. The time, type and volume of local anesthetic used, and VAS scores before and 15 minutes after the redose will be recorded.

All other clinical management will be as per routine, and study participation will not interfere with anesthetic or obstetric care. Anesthesiologists will manage breakthrough pain in the usual manner (assessment of stage of labor and extend/density of neuraxial blockade, followed by the appropriate maneuver to reestablish adequate analgesia).

Following delivery, the patient will be asked to give one final VAS score and her overall satisfaction with labor using a 100 mm unmarked line. Mode of delivery, as well as the duration of the 1st and 2nd stage of labor will be recorded by study personnel.

Patient Controlled Epidural Analgesia (PCEA) pump utilization data will be downloaded from epidural pumps after delivery. This will include the time to first PCEA request, the number of PCEA demands, the number of times that PCEA boluses were delivered, the total amount of local anesthetic consumed.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

Term, nulliparous, English-speaking patients with singleton vertex pregnancies, who were 18 years or older, who presented to the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital in spontaneous labor or for induction of labor were eligible to participate in the study

Exclusion Criteria:

History of chronic opioid analgesic use, prior opioid administration during labor, refusal of a vaginal examination prior to initiation of combined spinal-epidural (CSE) analgesia, or the presence of contraindications to neuraxial analgesia, such as coagulopathy or sepsis. Patients with cervical dilation > 5cm at the request for an epidural analgesia and women that were dilated > 5cm upon presentation to the labor and delivery unit were not approached for inclusion in the study; patients were excluded from the study after randomization if request for provider-administered supplemental bolus, or delivery, occurred within 90 minutes of intrathecal injection, or if there was a need for epidural catheter replacement during labor.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CADD-Solis pump (Smiths Medical)
The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25. — View Citation

Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. — View Citation

Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. — View Citation

Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. — View Citation

Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. — View Citation

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. — View Citation

Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Time to Provider Administered Supplemental Boluses Time to provider administered supplemental boluses measured in minutes epidural to first request of redose up to 10 hours
Other Mean Pain Score Weighted mean pain score (measured by the area under the VAS (Visual Analog Scale)-time curve calculated using the trapezoidal integration divided by the duration of labor analgesia).Visual Analog Scale is a 100 millimeter scale where 0 is no pain and 100 is worst pain imaginable. epidural placement to delivery, up to 36 hours.
Other Stage of Labor at Re-dose Request The stage of labor ( first or second) at the time of re-dose request. Through 2 stages of labor up to 24 hours
Other Number of Participants With Epidural Re-doses Total number of patients requiring epidural re-doses given by the provider. epidural placement to delivery, up to 36 hours.
Other Patient Satisfaction of Labor Anesthesia Patient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale. Up to 24 hours after delivery of baby
Primary Number of Participants Who Experienced Breakthrough Pain. Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers. epidural placement to delivery, up to 36 hours.
Secondary Total Bupivacaine Consumption Per Hour of Labor Analgesia Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses epidural placement to delivery, up to 36 hours.
Secondary Total Number of Requested PCEA Boluses Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered epidural placement to delivery, up to 36 hours.
Secondary Total Number of Delivered PCEA Boluses Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered. epidural placement to delivery, up to 36 hours.
Secondary Ratio of Total Number of PCEA Boluses Requested and Delivered The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered. epidural placement to delivery, up to 36 hours.
Secondary Satisfaction Scores Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management. up to 24 hours after delivery
See also
  Status Clinical Trial Phase
Completed NCT03539562 - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Withdrawn NCT04662450 - Evaluation and Management of Parturients' Pain Intensity N/A
Completed NCT02885350 - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour Phase 4
Completed NCT02550262 - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor N/A
Completed NCT01598506 - Intrathecal Hydromorphone for Labor Analgesia Phase 2
Withdrawn NCT01636999 - Comparing Sedara to Butorphanol in Early Labor N/A
Completed NCT00987441 - Epidural Labor Analgesia and Infant Neurobehavior N/A
Completed NCT00755092 - Effect of Doula in Nulliparas and Multiparas N/A
Terminated NCT00787176 - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes N/A
Recruiting NCT06036797 - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia Phase 2
Completed NCT05512065 - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women N/A
Completed NCT05327088 - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia Phase 2
Completed NCT03103100 - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation Phase 3
Recruiting NCT03623256 - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia Phase 4
Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
Completed NCT03712735 - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women Phase 4
Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A