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Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

Primary Purpose

Labor Pain, Induced; Birth

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Fentanyl Citrate
Lidocaine 1% Injectable Solution
Fentanyl Citrate
Sponsored by
Women's Hospital HUS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring epidural analgesia, spinal analgesia, labor pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signs a consent form to participate voluntarily into the trial
  2. Induced labor
  3. singleton pregnancy
  4. primiparous
  5. BMI 20-40 at the time of delivery
  6. No history of allergy for lidocaine or fentanyl
  7. sufficient command of Finnish language to understand the consent form and interview
  8. Cervical dilatation at maximum 4 cm at the time of intervention

Exclusion Criteria:

  1. Any contraindication for spinal or epidural analgesia
  2. Allergy for lidocaine or fentanyl
  3. The patient has received any opioid medication within 90 minutes prior to intervention

Sites / Locations

  • HUS/Women's hospital dept of anaesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spinal fentanyl

Epidural lidocaine and fentanyl

Arm Description

Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace. An epidural catheter is left in place for subsequent analgesic doses.

Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses.

Outcomes

Primary Outcome Measures

Analgesia at 20 minutes
Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value. 0 mm means no pain while 100 mm means worst possible pain.

Secondary Outcome Measures

Time until pain returns to 60 mm VAS
Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale
Ambulation during the analgesia provided by the intervention
HAs the parturient been walking during the analgesia provided by the intervention
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
Graded as normal, susceptible, pathological
Pruritus
The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable
SAtisfaction of the parturient with the analgesia provided by the intervention
On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.
Cervical dilatation rate cm/h during the analgesia intervention
(The cervical dilatation (1-10 cm) 1-3 h post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (h)
Use of oxytocin during the analgesia study period
Oxytocin administered i.v. during 0-30 min after the analgesia (yes or no)

Full Information

First Posted
November 22, 2020
Last Updated
August 28, 2023
Sponsor
Women's Hospital HUS
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1. Study Identification

Unique Protocol Identification Number
NCT04645823
Brief Title
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
Official Title
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's Hospital HUS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg). They will be monitored for the development of analgesia for a duration of 30 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Induced; Birth
Keywords
epidural analgesia, spinal analgesia, labor pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
60 parturients randomized to two different treatment arms (30 in each group)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The parturient and the midwife as well as the researcher doing the interview for analgesia will be masked. The anesthesiologist performing either spinal fentanyl administration or epidural analgesia will not be masked
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal fentanyl
Arm Type
Active Comparator
Arm Description
Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace. An epidural catheter is left in place for subsequent analgesic doses.
Arm Title
Epidural lidocaine and fentanyl
Arm Type
Experimental
Arm Description
Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses.
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Intervention Description
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% Injectable Solution
Intervention Description
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Intervention Description
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Primary Outcome Measure Information:
Title
Analgesia at 20 minutes
Description
Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value. 0 mm means no pain while 100 mm means worst possible pain.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Time until pain returns to 60 mm VAS
Description
Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale
Time Frame
30-180 minutes
Title
Ambulation during the analgesia provided by the intervention
Description
HAs the parturient been walking during the analgesia provided by the intervention
Time Frame
30-180 minutes
Title
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
Description
Graded as normal, susceptible, pathological
Time Frame
0-30 minutes
Title
Pruritus
Description
The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable
Time Frame
0-30 minutes
Title
SAtisfaction of the parturient with the analgesia provided by the intervention
Description
On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.
Time Frame
at 30 minutes
Title
Cervical dilatation rate cm/h during the analgesia intervention
Description
(The cervical dilatation (1-10 cm) 1-3 h post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (h)
Time Frame
0-180 min
Title
Use of oxytocin during the analgesia study period
Description
Oxytocin administered i.v. during 0-30 min after the analgesia (yes or no)
Time Frame
30 min

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All recruited patients are parturients undergoing induction of labor
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signs a consent form to participate voluntarily into the trial Induced labor singleton pregnancy primiparous BMI 20-40 at the time of delivery No history of allergy for lidocaine or fentanyl sufficient command of Finnish language to understand the consent form and interview Cervical dilatation at maximum 4 cm at the time of intervention Exclusion Criteria: Any contraindication for spinal or epidural analgesia Allergy for lidocaine or fentanyl The patient has received any opioid medication within 90 minutes prior to intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti J Vaananen, MD PhD
Organizational Affiliation
HUCH, Women's hospital/dept of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS/Women's hospital dept of anaesthesia
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor

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