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Trial record 11 of 58 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | pain

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

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ClinicalTrials.gov Identifier: NCT01943565
Recruitment Status : Terminated (Research question answered by another group of researchers (Sviggum et al))
First Posted : September 17, 2013
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dirk Varelmann, MD, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions: Healthy
Pain
Pregnancy
Interventions: Drug: Hydromorphone 25mcg
Drug: Hydromorphone 50mcg
Drug: Hydromorphone 100mcg
Drug: spinal anesthesia

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hydromorphone 25mcg

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

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Hydromorphone 50mcg

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

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Hydromorphone 100mcg

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

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)


Participant Flow:   Overall Study
    Hydromorphone 25mcg   Hydromorphone 50mcg   Hydromorphone 100mcg
STARTED   11   9   9 
COMPLETED   11   9   9 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hydromorphone 25mcg

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

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Hydromorphone 50mcg

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

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Hydromorphone 100mcg

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

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Total Total of all reporting groups

Baseline Measures
   Hydromorphone 25mcg   Hydromorphone 50mcg   Hydromorphone 100mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   10   30 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11 100.0%      9 100.0%      10 100.0%      30 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      11 100.0%      9 100.0%      10 100.0%      30 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   11   9   10   30 


  Outcome Measures

1.  Primary:   24hr Post-partum IV Opioid Requirement   [ Time Frame: 24hrs after administration of intrathecal hydromorphone ]

2.  Secondary:   Oxygen Saturation, Need for Supplemental Oxygen   [ Time Frame: 24hrs post administration of IT hydromorphone ]

3.  Secondary:   Patients With Nausea and Vomiting Requiring Rescue Medication   [ Time Frame: 24hrs post administration of IT hydromorphone ]

4.  Secondary:   Number of Patients With Hypothermia (Body Temperature < 95F/35C)   [ Time Frame: 24hrs post administration of IT hydromorphone ]

5.  Secondary:   Number of Patients With Visual Disturbances   [ Time Frame: 24hrs post administration of IT hydromorphone ]

6.  Secondary:   Number of Patients With Pruritus   [ Time Frame: 24hrs post administration of IT hydromorphone ]

7.  Secondary:   Intraoperative Vasopressor Use: Ephedrine Equivalents   [ Time Frame: Intraoperatively (at time of operation) ]

8.  Secondary:   Intraoperative Vasopressor Use: Phenylephrine Equivalents   [ Time Frame: Intraoperatively (at time of operation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dirk J Varelmann, MD
Organization: Brigham and Women's Hospital
phone: 617-732-8280
e-mail: dvarelmann@partners.org


Publications:

Responsible Party: Dirk Varelmann, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01943565     History of Changes
Other Study ID Numbers: 2013P001850
Hydromorphone_IT ( Other Identifier: BrighamHospital )
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: May 22, 2017
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017