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

NCT03129022 | Unknown DMC

• 1 other identifier: 168
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Successful epidural anaesthesia

ACTIVE COMPARATOR

It is defined as VAS score \<5, 30 min after a loading dose, given after the last attempt.

Procedure: epidural anaesthesia

Failed epidural anaesthesia

ACTIVE COMPARATOR

It is defined as VAS score ≥5, 30 min after a loading dose, given after the last attempt.

Procedure: epidural anaesthesia

Interventions

epidural anaesthesia PROCEDURE

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

Failed epidural anaesthesia; Successful epidural anaesthesia

Eligibility Criteria

• Age: 19 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Ahmed shaker, MD

CONTACT

asragab1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: April 30, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

EG (1)