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Dexamethasone for Post Cesarean Delivery Analgesia

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ClinicalTrials.gov Identifier: NCT01868633
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : June 2, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Unyime Ituk, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Postoperative Pain
Interventions Drug: Dexamethasone
Drug: Placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Period Title: Overall Study
Started 26 26
Completed 26 26
Not Completed 0 0
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine Total
Hide Arm/Group Description

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
26
 100.0%
52
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
31.69  (4.02) 31.65  (5.83) 31.67  (4.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
26
 100.0%
26
 100.0%
52
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Hispanic or Latino
2
   7.7%
2
   7.7%
4
   7.7%
Not Hispanic or Latino
24
  92.3%
24
  92.3%
48
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  11.5%
1
   3.8%
4
   7.7%
White
23
  88.5%
25
  96.2%
48
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Postoperative Analgesia
Hide Description Comparison of postoperative opioid analgesia use between the 2 groups
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Overall Number of Participants Analyzed 26 26
Median (Inter-Quartile Range)
Unit of Measure: milligrams of morphine
11.8
(5 to 20)
15
(5 to 22.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexamethasone & Spinal Morphine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Overall Number of Participants Analyzed 26 26
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pain at rest @ 0-6hr
1
(0 to 2)
1
(1 to 3)
Pain with movement @ 0-6hr
4
(1 to 5)
4.5
(3 to 5)
Pain at rest @ 6-12hr
1
(0 to 1)
2
(1 to 3)
Pain with movement @ 6-12hr
3
(2 to 4)
4
(4 to 5)
Pain at rest @ 12-24hr
1
(0 to 2)
1
(1 to 3)
Pain with movement @ 12-24hr
4
(3 to 5)
4
(3 to 5)
3.Secondary Outcome
Title Quality of Recovery
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Overall Number of Participants Analyzed 24 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
180  (10) 177  (10)
4.Secondary Outcome
Title Incidence and Severity of Nausea and Pruritus
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Overall Number of Participants Analyzed 26 26
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Nausea @ 0-6hr
6
(2 to 10)
2.5
(0 to 7)
Pruritus@ 0-6hr
5
(2 to 8)
3
(1 to 6)
Nausea @ 6-12hr
0
(0 to 3)
0
(0 to 2)
Pruritus @ 6-12hr
3
(2 to 7)
0
(0 to 2)
Nausea @12-24hr
0
(0 to 0)
0
(0 to 0)
Pruritus @ 12-24hr
2
(1 to 4)
1
(0 to 3)
5.Other Pre-specified Outcome
Title Number of Participants With Chronic Pain After Cesarean Delivery
Hide Description Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description:

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

Overall Number of Participants Analyzed 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame A safety analysis of adverse events was done by a clinician investigator not involved in study after enrollment of every 20 patients and at the 6th-week postnatal outpatient visit( That is 6 weeks after exposure to the intervention). Adverse event data collected included surgical wound examination findings (signs of infection, poor healing, wound breakdown), postpartum blood loss and vital signs ( blood pressure, heart rate and temperature)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Hide Arm/Group Description

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Placebo

All-Cause Mortality
Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone & Spinal Morphine Placebo Injection and Spinal Morphine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Unyime Ituk
Organization: University of Iowa
Phone: 3193562633
Responsible Party: Unyime Ituk, University of Iowa
ClinicalTrials.gov Identifier: NCT01868633     History of Changes
Other Study ID Numbers: 201210765
First Submitted: May 30, 2013
First Posted: June 4, 2013
Results First Submitted: October 26, 2016
Results First Posted: June 2, 2017
Last Update Posted: September 19, 2017