Analgesia in Labor, a Prospective Parallel Study to Compare Regional Analgesia and Intravenous (IV) Pethidine Analgesia

NCT01290289 | Completed

• 1 other identifier: 6111972
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare combined spinal epidural, epidural and IV pethidine analgesia and their effects on the mother, fetus, newborn and the course of labor.

Conditions

Labor Active Dilated Cm

Keywords

Labor; Epidural; Combined spinal epidural; pethidine

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale to assess pain control

  The Visual Analogue Pain Scale (VAS) (0 mm = no pain, 100 mm = worst pain imaginable) was measured before administration of analgesia, 10 and 30 minutes after administration of each analgesic dose until the delivery of the baby.

  24 hours

Secondary Outcomes (4)

• The degree of motor block

  24 hours

• Number of top-ups

  24 hours

• Adverse effects

  24 hours

• Labour Duration

  24 hours

Study Arms (1)

Epidura, combined spinal epidura & IV

ACTIVE COMPARATOR

Gp 1: received CSE analgesia, 25µg of fentanyl injected intrathecally \& a bolus of 10 ml of 0.5% lidocaine injected epidurally. Gp 2: received CSE analgesia, 25µg of fentanyl injected intrathecally \& a bolus of 10 ml of 0.0625% bupivacaine injected epidurally. Gp 3: received 50µg of E fentanyl analgesia, injected intrathecally \& a bolus of 10 ml of 0.5% lidocaine, followed by lidocaine E top-ups. Gp 4: received 50µg of E fentanyl injected intrathecally and a bolus dose of 10 ml of 0.125% bupivacaine, followed by E bupivacaine top-ups. Gp 5: 50mg of IV pethidine was administered as a loading dose, followed by 0.5 mg/kg.

Other: Epidura, CSE & IV

Interventions

Epidura, CSE & IV OTHER

Gp 1: received CSE analgesia: 25µg of fentanyl \& a bolus dose of 10 ml of 0.5% lidocaine was injected epidurally. E top-ups of 5-10 ml of 0.5-0.8% lidocaine were then injected. Gp 2: received CSE analgesia: 25µg of fentanyl \& a bolus dose of 10 ml of 0.0625% bupivacaine was injected epidurally. E top-ups of 5-10 ml of 0.0625-0.25% bupivacaine were then injected. Gp 3: received 50µg of E fentanyl analgesia \& a bolus of 10 ml of 0.5% lidocaine was administered, followed by lidocaine E top-ups of 5-10 ml of 0.5-0.8%. Gp 4: received analgesia: 50µg of E fentanyl \& a bolus dose of 10 ml of 0.125% bupivacaine was administered, followed by E bupivacaine top-ups of 5-10 ml of 0.125-0.25%. Gp 5: 50mg of IV pethidine was administered as loading dose, followed by 0.5 mg/kg.

Epidura, combined spinal epidura & IV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• full-term, ASA physical status I or II nulliparous women in active labor with cervical dilatation of 5 cm and cephalic presenting fetus

You may not qualify if:

• Patients who had diabetes mellitus, neurological disease, pre-eclampsia, or patients who had received parenteral analgesics or patients with contraindication to E or spinal analgesia, or patients with sensitivity to local anesthetics or opioids were excluded from the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El-Galaa Hospital

Cairo, Egypt

Location

Study Officials

• Nirmeen Sabry, Ph.D

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: February 7, 2011

Record last verified: 2009-07

Locations

EG (1)