Back to resultsDexamethasone for Post Cesarean Delivery Analgesia
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Cesarean delivery, Analgesia, Pain, Dexamethasone, intrathecal morphine, spinal anesthesia
Eligibility Criteria
Inclusion Criteria:
- English Speaking
- Non-laboring women
- Scheduled Elective Cesarean section under spinal anesthesia
- American Society of Anesthesiologists I-II physical status
Exclusion Criteria:
- Contraindications to spinal anesthesia
- allergy to study medication
- patients with allergy to morphine
- patients with uncontrolled hypertension
- history of peptic ulcer disease
- liver cirrhosis
- diabetes mellitus
- glaucoma
- known IV drug abusers
- patients with chronic pain or on long term opioids
- patients administered steroids in the past week
- women with fetuses having known congenital abnormalities
- psychiatric illness such that they are unable to comprehend or participate in study questions
- patients on antiviral medications or live virus vaccines would also be excluded.
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone & spinal morphine
Placebo injection and spinal morphine
Arm Description
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Outcomes
Primary Outcome Measures
Postoperative Analgesia
Comparison of postoperative opioid analgesia use between the 2 groups
Secondary Outcome Measures
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement
Quality of Recovery
Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group
Incidence and Severity of Nausea and Pruritus
Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01868633
Brief Title
Dexamethasone for Post Cesarean Delivery Analgesia
Official Title
The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.
We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
Detailed Description
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cesarean delivery, Analgesia, Pain, Dexamethasone, intrathecal morphine, spinal anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone & spinal morphine
Arm Type
Active Comparator
Arm Description
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Arm Title
Placebo injection and spinal morphine
Arm Type
Placebo Comparator
Arm Description
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Postoperative Analgesia
Description
Comparison of postoperative opioid analgesia use between the 2 groups
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Description
Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement
Time Frame
24 hours
Title
Quality of Recovery
Description
Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group
Time Frame
48 hours
Title
Incidence and Severity of Nausea and Pruritus
Description
Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Number of Participants With Chronic Pain After Cesarean Delivery
Description
Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English Speaking
Non-laboring women
Scheduled Elective Cesarean section under spinal anesthesia
American Society of Anesthesiologists I-II physical status
Exclusion Criteria:
Contraindications to spinal anesthesia
allergy to study medication
patients with allergy to morphine
patients with uncontrolled hypertension
history of peptic ulcer disease
liver cirrhosis
diabetes mellitus
glaucoma
known IV drug abusers
patients with chronic pain or on long term opioids
patients administered steroids in the past week
women with fetuses having known congenital abnormalities
psychiatric illness such that they are unable to comprehend or participate in study questions
patients on antiviral medications or live virus vaccines would also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Unyime Ituk, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17900579
Citation
Fujii Y, Nakayama M. Dexamethasone for reduction of nausea, vomiting and analgesic use after gynecological laparoscopic surgery. Int J Gynaecol Obstet. 2008 Jan;100(1):27-30. doi: 10.1016/j.ijgo.2007.07.017. Epub 2007 Sep 27.
Results Reference
background
PubMed Identifier
21297442
Citation
Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, Vaughn J. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011 Apr;114(4):882-90. doi: 10.1097/ALN.0b013e3181ec642e.
Results Reference
background
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Dexamethasone for Post Cesarean Delivery Analgesia
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