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Opioid Analgesic

TAP Catheter vs. Spinal Morphine for Post-Cesarean Pain

N/A

Waitlist Available

Research Sponsored by Stamford Anesthesiology Services, PC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients age 18 - 45 years of age undergoing cesarean section under spinal anesthesia

Be between 18 and 65 years old

Must not have

Patients without the mental capacity to consent for the procedure/study

Patients with history of diabetes or chronic steroid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether a long-acting local anesthetic infusion is better than spinal morphine for post-cesarean recovery, in terms of nausea, pruritus, and pain.

Who is the study for?

This trial is for English-reading women aged 18-45 undergoing a cesarean section with spinal anesthesia. It's not suitable for those lacking mental capacity to consent, needing a translator, having additional procedures, diabetes or chronic steroid use history, recent opioid use, or allergies to local anesthetics.

What is being tested?

The study compares the effectiveness of TAP catheter infusions using long-acting local anesthetic against intrathecal morphine in managing postoperative pain after cesarean sections. The goal is to see if TAP catheters can improve recovery quality by reducing side effects like nausea and itching.

What are the potential side effects?

Intrathecal morphine may cause significant nausea and itching. While the TAP catheter aims to reduce these issues by delivering local anesthetic directly near nerves around the surgical site, potential side effects are not detailed but could include discomfort at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old and will have a cesarean section with spinal anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or make decisions about the study.

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I have diabetes or I've been using steroids for a long time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of recovery after cesarean section

Secondary study objectives

Incidence of nausea/vomiting

incidence and severity of pruritus

overall oral narcotic use during the 48 hours post-operatively

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: TAP catheterActive Control1 Intervention

Indwelling TAP catheter placed at the end of c-section. It will be dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen OnQ C-block pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The catheters will run at 7cc/hr/side for 50 hrs.

Group II: intrathecal morphineActive Control1 Intervention

0.3 mg of intrathecal morphine

0 / 3Eligibility criteria met