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NCT Number: NCT05131178

Post-operative Cesarean Trial of Pain Control

This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.

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Key information

Conditions

Post-operative Pain Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80011, United States

Location status: Recruiting

Location contact

Liz Torres

CONTACT

[email protected]

720-777-1661

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant patients 18 years of age or older
  • Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC

Exclusion criteria

  • Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
  • Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
  • Contraindication to neuraxial anesthesia
  • Known allergies to common anesthetic medications
  • Inability to consent to study procedures
  • Patient receiving general anesthesia

Treatment and study plan

ON-Q Pump® with continuous infusion of bupivacaine

Device

270 ml of 0.5 % bupivacaine. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.

ON-Q Pump® with continuous infusion of saline

Device

270 mL of normal saline. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.

Primary outcomes

  1. Total postoperative opioid use

    Time frame: Post-operative day 4

    Total postoperative opioid use in morphine equivalents through discharge

Secondary outcomes

  1. Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score

    Time frame: At hospital discharge (about post-operative day 5)

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  2. Antiemetic use at Baseline

    Time frame: Baseline

    Daily antiemetic use by number of doses through discharge

  3. Antiemetic use at post-operative day 1

    Time frame: Post-operative day 1

    Daily antiemetic use by number of doses through discharge

  4. Antiemetic use at post-operative day 2

    Time frame: Post-operative day 2

    Daily antiemetic use by number of doses through discharge

  5. Antiemetic use at post-operative day 3

    Time frame: Post-operative day 3

    Daily antiemetic use by number of doses through discharge

  6. Antiemetic use at post-operative day 4

    Time frame: Post-operative day 4

    Daily antiemetic use by number of doses through discharge

  7. Antiemetic use at hospital discharge (about post-operative day 5)

    Time frame: At hospital discharge (about post-operative day 5)

    Daily antiemetic use by number of doses through discharge

  8. Visual Analog Scale (VAS) Pain Score at Baseline

    Time frame: Baseline

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  9. Visual Analog Scale (VAS) Pain Score at post-operative day 1

    Time frame: Post-operative day 1

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  10. Visual Analog Scale (VAS) Pain Score at post-operative day 2

    Time frame: Post-operative day 2

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  11. Visual Analog Scale (VAS) Pain Score at post-operative day 3

    Time frame: Post-operative day 3

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  12. Visual Analog Scale (VAS) Pain Score at post-operative day 4

    Time frame: Post-operative day 4

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).

  13. Time to advance to regular diet

    Time frame: Up to post-operative day 4

    Time to advance to regular diet through discharge

  14. Time to first ambulation

    Time frame: Up to post-operative day 4

    Time to first ambulation

  15. Return on bowel function

    Time frame: Up to post-operative day 4

    Return on bowel function (pass gas or bowel movement)

  16. Edinburgh Depression scale at hospital discharge (about post-operative day 5)

    Time frame: At hospital discharge (about post-operative day 5)

    The 10-item Edinburgh Depression Scale (EDS) measures depressive symptoms. It includes three sub-scales: anhedonia, anxiety and depression. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Manager

CONTACT

[email protected]

720-777-7080

Deion Pena

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Avanos Medical
  • Children's Hospital Colorado
  • Colorado Fetal Care Center

Registry information

Official study title

Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 23, 2021
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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