Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Sufentanil (Opioid plus local anesthetic); Drug: Sole local anesthetic; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02036242

NJFY13007

JQX12009 (Other Grant/Funding Number)

Details and patient eligibility

About

It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.

Enrollment: 500 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparas
• Request epidural analgesia
• Chinese

Exclusion criteria

• Allergic to opioid or local anesthetics
• Fail to perform epidural puncture and catheterization
• Organ dysfunction
• Contraindications for epidural anesthesia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Sole local anesthetic

Experimental group

Description:

Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently

Treatment:

Drug: Ropivacaine

Drug: Sole local anesthetic

Opioid plus local anesthetic

Active Comparator group

Description:

Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently

Treatment:

Drug: Ropivacaine

Drug: Sufentanil (Opioid plus local anesthetic)