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Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.
A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belladonna and Opium Suppositories | Experimental | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
|
| Placebo Suppositories | Placebo Comparator | Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belladonna and Opium Suppositories | Drug | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Hour 4 | Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." | 4 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Hour 12 | Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." | 12 hours after surgery. |
| Pain at Hour 20 | Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Butler, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
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Subjects were recruited at the Mayo Clinic in Arizona, United States from January 2011 to April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belladonna and Opium Suppositories | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| FG001 | Placebo Suppositories | Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belladonna and Opium Suppositories | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| BG001 | Placebo Suppositories |
| 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 | Pain at Hour 4 | Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." | Posted | Mean | Standard Deviation | units on a scale | 4 hours following surgery |
|
Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
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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 | Belladonna and Opium Suppositories | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Sepsis | General disorders | Non-systematic Assessment | Within 24 hours of surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia Postoperative | Blood and lymphatic system disorders | Non-systematic Assessment | Within 24 hours of surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristina A. Butler | Mayo Clinic | 480-301-5934 | butler.kristina@mayo.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo Suppositories | Drug | Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
|
| 20 hours after surgery. |
| Narcotic Rescue Medication | Use of all ancillary narcotic medications was taken from the medical record. | For 24 hours following surgery |
| Number of Subjects With Nausea | This information was taken from the medical record. | Approximately 12 hours after surgery |
| Number of Subjects With Vomiting | This information was taken from the medical record. | Within 20 hours of surgery |
| Number of Times Antiemetic Rescue Medication Was Used | First 24 hours after surgery |
| Number of Subjects Who Used Antiemetic Rescue Medications | First 24 hours after surgery |
| Satisfaction With Pain Relief | Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied." | Approximately 24 hours following surgery |
| Multiple Studies |
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| Rectotomy |
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| Drug did not arrive in time |
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| Drug not administered |
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| Surgery Changed |
|
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pelvic Organ Prolapse | Number | participants |
|
| Procedure time | Mean | Standard Deviation | minutes |
|
| Estimated Blood Loss | Mean | Standard Deviation | mL |
|
| Preoperative Pain | Pain was recorded on a validated numeric pain scale (1-10), with 0 = no pain and 10 = worst pain imaginable. Not all participants completed the pain scale, therefore the populations analyzed were Belladonna and Morphine Suppository Arm (N=39), Placebo Suppository Arm (N=45). | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Pain at Hour 12 | Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." | Posted | Mean | Standard Deviation | units on a scale | 12 hours after surgery. |
|
|
|
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| Secondary | Pain at Hour 20 | Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable." | Posted | Mean | Standard Deviation | units on a scale | 20 hours after surgery. |
|
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|
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| Secondary | Narcotic Rescue Medication | Use of all ancillary narcotic medications was taken from the medical record. | Posted | Mean | Standard Deviation | mg IV morphine equivalents | For 24 hours following surgery |
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| Secondary | Number of Subjects With Nausea | This information was taken from the medical record. | Posted | Number | participants | Approximately 12 hours after surgery |
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| Secondary | Number of Subjects With Vomiting | This information was taken from the medical record. | Posted | Number | participants | Within 20 hours of surgery |
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| Secondary | Number of Times Antiemetic Rescue Medication Was Used | Posted | Mean | Standard Deviation | number of times antiemetics used | First 24 hours after surgery |
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| Secondary | Number of Subjects Who Used Antiemetic Rescue Medications | Posted | Number | participants | First 24 hours after surgery |
|
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| Secondary | Satisfaction With Pain Relief | Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied." | Posted | Mean | Standard Deviation | units on a scale | Approximately 24 hours following surgery |
|
|
|
|
| 1 |
| 41 |
| 24 |
| 41 |
| EG001 | Placebo Suppositories | Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | 0 | 49 | 27 | 49 |
|
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Postoperative Ileus | Gastrointestinal disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Procedural Hypertension | Cardiac disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Pruritis Generalized | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Sinus Tachycardia | Cardiac disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Sleep Apnea Syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Procedural Hypotension | Cardiac disorders | Non-systematic Assessment | Within 24 hours of surgery |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Within 7 days of surgery |
|
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