Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study

NCT01943565 | Terminated Phase 4 Results

• 2 other identifiers: 2013P001850Hydromorphone_IT
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery. For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.

Conditions

Healthy; Pain; Pregnancy

Keywords

Pregnancy; Healthy; Intrathecal; Opioids; Spinal; Anesthesia; Pain; Cesarean; Delivery; Human

Outcome Measures

Primary Outcomes (1)

• 24hr Post-partum IV Opioid Requirement

  Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.

  24hrs after administration of intrathecal hydromorphone

Secondary Outcomes (7)

• Oxygen Saturation, Need for Supplemental Oxygen

  24hrs post administration of IT hydromorphone

• Patients With Nausea and Vomiting Requiring Rescue Medication

  24hrs post administration of IT hydromorphone

• Number of Patients With Hypothermia (Body Temperature < 95F/35C)

  24hrs post administration of IT hydromorphone

• Number of Patients With Visual Disturbances

  24hrs post administration of IT hydromorphone

• Number of Patients With Pruritus

  24hrs post administration of IT hydromorphone

Study Arms (3)

Hydromorphone 25mcg

ACTIVE COMPARATOR

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Drug: Hydromorphone 25mcg; Drug: spinal anesthesia

Hydromorphone 50mcg

ACTIVE COMPARATOR

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Drug: Hydromorphone 50mcg; Drug: spinal anesthesia

Hydromorphone 100mcg

ACTIVE COMPARATOR

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Drug: Hydromorphone 100mcg; Drug: spinal anesthesia

Interventions

Hydromorphone 25mcg DRUG

Intrathecal Hydromorphone 25mcg

Also known as: HM25

Hydromorphone 25mcg

Hydromorphone 50mcg DRUG

Intrathecal Hydromorphone 50mcg

Also known as: HM50

Hydromorphone 50mcg

Hydromorphone 100mcg DRUG

Intrathecal Hydromorphone 100mcg

Also known as: HM100

Hydromorphone 100mcg

spinal anesthesia DRUG

bupivacaine 0.75% 1.6 mL (12mg)

Hydromorphone 100mcg; Hydromorphone 25mcg; Hydromorphone 50mcg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy at-term parturients undergoing elective cesarean delivery under spinal anesthesia

You may not qualify if:

• Emergency cesarean delivery
• Respiratory disease
• significant comorbidities: preeclampsia, insulin-dependent diabetes mellitus
• obstructive sleep apnea
• body mass index \> 35kg/m2
• \<18yrs
• documented intolerance or allergy to systemic or neuraxial opioids
• patient with a history of chronic opioid or current use of opioids

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available.

  PMID: 373503 BACKGROUND

• Ross BK, Hughes SC. Epidural and spinal narcotic analgesia. Clin Obstet Gynecol. 1987 Sep;30(3):552-65. doi: 10.1097/00003081-198709000-00010. No abstract available.

  PMID: 2888557 BACKGROUND

• Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.

  PMID: 9952150 BACKGROUND

• Milner AR, Bogod DG, Harwood RJ. Intrathecal administration of morphine for elective Caesarean section. A comparison between 0.1 mg and 0.2 mg. Anaesthesia. 1996 Sep;51(9):871-3. doi: 10.1111/j.1365-2044.1996.tb12622.x.

  PMID: 8882255 BACKGROUND

• Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.

  PMID: 21562420 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Hydromorphone; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dirk J Varelmann, MD
• Organization: Brigham and Women's Hospital

dvarelmann@partners.org

617-732-8280

Study Officials

• Dirk J Varelmann, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Anaesthesiology

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-05

Locations

US (1)