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The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.
Steroids have been used to reduce inflammation and tissue damage in a variety of conditions, have potent immunomodulatory effects, and are a mainstay in the treatment of acute allograft rejection. Dexamethasone has been shown to be a safe and effective anti-emetic therapy for patients undergoing cesarean section surgery with spinal anesthesia containing morphine.
However, recent evidence suggests that dexamethasone may also play a role in reducing post-operative pain and opioid consumption. Early studies in patients undergoing dental procedures showed that glucocorticoids were effective in reducing postoperative pain and edema. Multiple recent studies have also investigated the potential analgesic benefit of a single perioperative dose of dexamethasone, but the results have been inconsistent. The effect of single-dose, intraoperative, intravenous dexamethasone therapy on post-operative pain and opioid consumption has not yet been studied in patients undergoing cesarean section.
Pain is a significant source of morbidity for many women following cesarean section, and has serious consequences beyond the immediate post-operative period. Patients with poorly-controlled pain may have difficulty with ambulation that can lead to atelectasis, pneumonia, and venous thromboembolism.
Poor maternal pain control may also affect the infant by interfering with bonding and breastfeeding. Reduction of post-operative opioid consumption is desirable because it may also reduce the incidence of opioid-induced side effects such as sedation, constipation, nausea, vomiting and pruritus. Some evidence suggests that the severity of post-operative pain following cesarean section may predict progression to chronic pain, and postpartum depression.
Although 10 to 18% of women who undergo cesarean section will experience chronic pain following surgery, it is difficult to predict those patients who will experience this complication. Recent investigations have shown that patient responses to standardized painful stimuli prior to surgery help predict severity of post-operative pain and possibly progression to chronic pain. This type of information could potentially help to tailor the clinical management of patients at risk for severe and/or chronic post-operative pain to improve outcomes for these patients. Landau and colleagues have described a simple and minimally-invasive method of assessing response to noxious stimuli using a von-Frey filament to obtain a mechanical temporal summation score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8 mg IV given intraoperatively as a one-time dose. |
|
| Placebo | Placebo Comparator | Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 8 mg IV (as a one time dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption at 24 Hours Post-op | The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine | 24 hours from admission to Postanesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores Between the Groups at 2 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | 2 hours from admission to postanesthesia care unit (PACU) |
| Time to Administration of First Rescue Analgesic Request Between the Groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence Allen, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34002866 | Derived | Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3. |
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Of the 52 subjects that were enrolled, 3 subjects were not randomized due to later being deemed ineligible for the study; therefore, 49 subjects started on study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose) |
| FG001 | Placebo | Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose) |
| BG001 | Placebo | Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Consumption at 24 Hours Post-op | The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine | Posted | Median | Inter-Quartile Range | milligram | 24 hours from admission to Postanesthesia care unit (PACU) |
|
Adverse Events were collected from the time PACU admission until 48 hours from PACU admission.
Adverse Event reporting for this study were limited to surgical site infections and wound dehiscence assessed by the obstetricians daily
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose) |
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The study was ended prior to completion of total planned enrollment of 104 subjects due to a change in clinical practice regarding post-operative pain medications that would have confounded the results of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Terrence K Allen | Duke University Medical Center | 9196682024 | terrence.allen@duke.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo |
| Drug |
Sodium Chloride 0.9% -5 ml |
|
|
Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain |
| PACU admission to discharge from PACU an average of 2 hours |
| Cumulative Opioid Consumption at 48 Hours Between the Groups | The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine | Admission to PACU through 48 hours |
| Pain Scores Between the Groups at 24 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | 24 hours from PACU admission |
| Pain Scores Between the Groups at 48 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | 48 hours from PACU Admission |
| Cumulative Opioid Consumption at 24 Hours Between MTS Groups | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive. | 24 hours from admission to Postanesthesia care unit (PACU) |
| Incidence of Chronic Persistent Pain at 8 Weeks | Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery | 8 weeks from the day of surgery |
| Incidence of Chronic Persistent Pain at 6 Months | Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery | 6 months from the day of surgery |
| Pain Scores Between MTS Groups | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive. | 24 hours after PACU admission |
| Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic. | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
| Incidence of Intraoperative Pruritus | pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
| Incidence of Postoperative Pruritus | Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated. If median score >0 then patient experienced postoperative pruritus. | 48 hours from admission to PACU |
| Need for Intraoperative Analgesic Supplementation | Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
| Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV. Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic | 2, 24 and 48 hours from PACU admission |
| Incidence of Wound Complications | Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery | 24 hours from PACU admission |
| Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP) | Intraoperatively |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Pain Scores Between the Groups at 2 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | Posted | Median | Inter-Quartile Range | units on a scale | 2 hours from admission to postanesthesia care unit (PACU) |
|
|
|
|
| Secondary | Time to Administration of First Rescue Analgesic Request Between the Groups. | Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain | Analysis was based on all 47 patients who completed the study. | Posted | Median | Inter-Quartile Range | minutes | PACU admission to discharge from PACU an average of 2 hours |
|
|
|
|
| Secondary | Cumulative Opioid Consumption at 48 Hours Between the Groups | The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine | Posted | Median | Inter-Quartile Range | milligrams | Admission to PACU through 48 hours |
|
|
|
|
| Secondary | Pain Scores Between the Groups at 24 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours from PACU admission |
|
|
|
|
| Secondary | Pain Scores Between the Groups at 48 Hours. | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. | Posted | Mean | Inter-Quartile Range | units on a scale | 48 hours from PACU Admission |
|
|
|
|
| Secondary | Cumulative Opioid Consumption at 24 Hours Between MTS Groups | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive. | Analysis was based on all 47 patients who completed the study. | Posted | Median | Inter-Quartile Range | milligrams | 24 hours from admission to Postanesthesia care unit (PACU) |
|
|
|
|
| Secondary | Incidence of Chronic Persistent Pain at 8 Weeks | Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery | Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group. | Posted | Count of Participants | Participants | 8 weeks from the day of surgery |
|
|
|
|
| Secondary | Incidence of Chronic Persistent Pain at 6 Months | Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery | Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group. | Posted | Count of Participants | Participants | 6 months from the day of surgery |
|
|
|
|
| Secondary | Pain Scores Between MTS Groups | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours after PACU admission |
|
|
|
|
| Secondary | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic. | Posted | Count of Participants | Participants | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
|
|
|
|
| Secondary | Incidence of Intraoperative Pruritus | pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus | No data was collected on intraoperative pruritus on any participants. | Posted | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
|
|
| Secondary | Incidence of Postoperative Pruritus | Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated. If median score >0 then patient experienced postoperative pruritus. | Posted | Count of Participants | Participants | 48 hours from admission to PACU |
|
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|
|
| Secondary | Need for Intraoperative Analgesic Supplementation | Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain | Posted | Count of Participants | Participants | From spinal anesthesia placement to end of surgery, approximately 70 minutes |
|
|
|
|
| Secondary | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV. Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic | Posted | Count of Participants | Participants | 2, 24 and 48 hours from PACU admission |
|
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|
|
| Secondary | Incidence of Wound Complications | Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery | Posted | Count of Participants | Participants | 24 hours from PACU admission |
|
|
|
| Secondary | Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP) | No data was collected intraoperatively using CNAP on any participants. | Posted | Intraoperatively |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Placebo | Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml | 0 | 24 | 0 | 24 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Superiority |
Pain Score with movement at 2 hours |
| Superiority |
Pain Score with movement at 24 hours |
| Superiority |
Pain Scores with movement at 48 hours |
| Pain scores on movement at 24h | Wilcoxon (Mann-Whitney) | 1.000 | Superiority | We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement. |
| Incidence of intraoperative vomiting |
|
| 0.676 |
| Superiority |
| Fisher Exact | 1.000 | Superiority |
| Incidence of PONV at 48 hours |
|
| Incidence of PONV at 2 h |
|
| 0.028 |
| Superiority |
| Fisher Exact | 1.000 | Superiority |
| Chi-squared | 0.188 | Superiority |