Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses

Labor Pain Clinical Trial

Official title:

Effect of Epidural Infusion Bolus Delivery Rate on the Duration of Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340806
• Other study ID #: STU00100819
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

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