Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

NCT ID: NCT00361712

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2006-07-31

Brief Summary

During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.

Epidural analgesia is commonly performed after the parturient feels labor pain.

We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.

Detailed Description

The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.

Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.

Parturients will be divided into two groups:

• Group I- those who have painless contractions awaiting augmentation of labor.
• Group II- parturients with cervical dilatation and painful labor (VAS >5).

Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.

Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes.

Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery.

These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18.

The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.

Conditions

Obstetric Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preemptive epidural analgesia

Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3).

Group Type: EXPERIMENTAL

Preemptive epidural analgesia

Intervention Type: PROCEDURE

Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.

Standard of care

Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5)

Interventions

Preemptive epidural analgesia

Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.

Intervention Type: PROCEDURE

Standard of care

Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age>18

2. Singleton pregnancy with no known fetal malformations

3. Above or equal to 38 weeks of pregnancy

Exclusion Criteria

1. Systemic medical illnesses

2. Chronic medications except for iron and vitamins

3. Women developing fever > 380C

4. Women with history of delivery of children with cerebral palsy

5. History of infertility

6. Premature contractions

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sharonorbach

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Orbach-Zinger, M.D.

Role: STUDY_DIRECTOR

Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital

Locations

Rabin Medical Center/Beilinson Campus

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

003692

Identifier Type: -

Identifier Source: org_study_id