Clinical trial NCT03129022: Failed Epidural Anesthesia During Labor: Evaluation of Risk Factors and Outcome
Official title: Failed Epidural Anesthesia During Labor: Evaluation of Risk Factors and Impact on Labor ,Maternal and Fetal Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Delivery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: duration of first stage of labor
timeFrame: from start of cervical dilatation till full cervical dilatation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maged
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: