Failed Epidural Anesthesia During Labor: Evaluation of Risk Factors and Outcome

Failed Epidural Anesthesia During Labor: Evaluation of Risk Factors and Impact on Labor ,Maternal and Fetal Outcomes

Women requesting epidural analgesia will receive a bolus of intravenous infusion of lactated Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip clear catheter with three lateral orifices (Portex, Smith Medical, Hythe, UK) were used in the sitting or lateral position, with a loss-of-resistance to air technique. Epidural catheters will be inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine 2% iss initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is established and maintained throughout labor and delivery using 0.125% bupivacaine with fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out intervals, continued at the same bolus dose until delivery.

Pain was evaluated using a 0-10 cm visual analogue scale (VAS) before, 15 and 30 min after the loading dose followed by hourly assessment until delivery. VAS score assessment was based specifically on abdominal or back pain resulting from contractions

Study Overview

• Status: Unknown
• Conditions: Vaginal Delivery
• Intervention / Treatment: Procedure: epidural anaesthesia

Detailed Description

Women requesting epidural analgesia will receive a bolus of intravenous infusion of lactated Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip clear catheter with three lateral orifices (Portex, Smith Medical, Hythe, UK) were used in the sitting or lateral position, with a loss-of-resistance to air technique. Epidural catheters will be inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine 2% iss initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is established and maintained throughout labor and delivery using 0.125% bupivacaine with fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out intervals, continued at the same bolus dose until delivery.

Pain was evaluated using a 0-10 cm visual analogue scale (VAS) before, 15 and 30 min after the loading dose followed by hourly assessment until delivery. VAS score assessment was based specifically on abdominal or back pain resulting from contractions. Failed epidural is defined as VAS score ≥5, 30 min after a loading dose, given after the last attempt. Women who had a repeated attempt due to VAS ≥5 at 30 min or dural puncture or required repositioning of the catheter, resulting in subsequent pain relief expressed as VAS score <5 were not considered to have a Failed epidural. VAS score is assessed by obstetrician and not the anesthesiologist who performed the block. Furthermore, intrapartum vaginal examinations to assess cervical dilatation and fetal head station were also performed by experienced obstetrician.

As part of the study, the women's satisfaction was assessed the morning following delivery using a 1-5 satisfaction scale, where score 1 corresponded to very unsatisfied and score 5 corresponded to very satisfied. Before satisfaction assessment, all women who agreed to participate signed an informed consent and then relevant data was collected from the participants' medical charts.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Recruiting
    • Ahmed Maged
    • Contact: Ahmed Maged, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ≥34 weeks of gestation
• receiving epidural analgesia during labor,

Exclusion Criteria:

• Women who had a planned cesarean delivery,
• intrauterine fetal death
• non-vertex presentation
• delivered at less than 30 min after epidural insertion
• contraindication for epidural analgesia (i.e., thrombocytopenia <100,000 cells/μl, ongoing thromboprophylaxis with low-molecular-weight or unfractionated heparin, and bacteremia or infection at the needle-puncture site)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Successful epidural anaesthesia; It is defined as VAS score <5, 30 min after a loading dose, given after the last attempt.	Procedure: epidural anaesthesia; Women requesting epidural analgesia received a bolus of intravenous infusion of lactated Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip clear catheter with three lateral orifices were used in the sitting or lateral position, with a loss-of-resistance to air technique. Epidural catheters were routinely inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine 2% was initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is maintained throughout labor using 0.125% bupivacaine with fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out intervals
Active Comparator: Failed epidural anaesthesia; It is defined as VAS score ≥5, 30 min after a loading dose, given after the last attempt.	Procedure: epidural anaesthesia; Women requesting epidural analgesia received a bolus of intravenous infusion of lactated Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip clear catheter with three lateral orifices were used in the sitting or lateral position, with a loss-of-resistance to air technique. Epidural catheters were routinely inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine 2% was initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is maintained throughout labor using 0.125% bupivacaine with fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of first stage of labor	effect of success and failure of epidural on duration of first stage of labor (..before, 15 and 30 min after the loading dose followed by hourly assessment until delivery..)	from start of cervical dilatation till full cervical dilatation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No