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Completed

NCT Number: NCT01598545

Hydromorphone and C-section

This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy women undergoing cesarean section

Exclusion criteria

  • Any comorbidities other than obesity, hypertension, fetal anomalies

Treatment and study plan

Hydromorphone

Drug

Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

Primary outcomes

  1. Pain Scores, Visual Analogue Pain Scale

    Time frame: 12 hours after intrathecal injection

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Secondary outcomes

  1. Pain Scores, Visual Analogue Pain Scale

    Time frame: Baseline

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

  2. Pain Scores, Visual Analogue Pain Scale

    Time frame: 6 hours after intrathecal injection

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

  3. Pain Scores, Visual Analogue Pain Scale

    Time frame: 18 hours after intrathecal injection

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

  4. Pain Scores, Visual Analogue Pain Scale

    Time frame: 24 hours after intrathecal injection

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Dec 17, 2014

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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