Dexamethasone for Post Cesarean Delivery Analgesia

Postoperative Pain Clinical Trial

Official title:

The Effect of a Single Intraoperative Dose of Dexamethasone in Combination With Intrathecal Morphine for Post Cesarean Delivery Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868633
• Other study ID #: 201210765
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: August 24, 2017
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone

• Placebo

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Sep 27. Retraction in: Int J Gynaecol Obstet. 2013 Apr;121(1):97. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Chronic Pain After Cesarean Delivery	Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups	6 months
Primary	Postoperative Analgesia	Comparison of postoperative opioid analgesia use between the 2 groups	24 hours
Secondary	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	24 hours
Secondary	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	48 hours
Secondary	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)	24 hours