Eligibility Module

Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module


Ignite Creation Date: 2025-12-25 @ 4:01 AM
Ignite Modification Date: 2025-12-25 @ 4:01 AM
NCT ID: NCT01170702
Eligibility Criteria: Inclusion Criteria: * ASA II-III patient * \> 18 years of age who is pregnant * presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI \>40 kg/m2. Exclusion Criteria: * \< 18 years of age * contraindication to placement of a spinal anesthetic * contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs) * patients receiving medical therapies considered to result in tolerance to opioids * patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient * patients with a history of diabetes mellitus * patients undergoing a vertical midline skin incision * patients who are undergoing a cesarean delivery after a failed vaginal trial of labor * patients who had a prior epidural placed for labor analgesia during the same hospital encounter.
Healthy Volunteers: False
Sex: FEMALE
Minimum Age: 18 Years
Study: NCT01170702
Study Brief:
Protocol Section: NCT01170702