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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
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 administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Mayo Clinic
Phoenix, Arizona, United States
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."
Time frame: 4 hours following surgery
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."
Time frame: 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."
Time frame: 20 hours after surgery.
Narcotic Rescue Medication
Use of all ancillary narcotic medications was taken from the medical record.
Time frame: For 24 hours following surgery
Number of Subjects With Nausea
This information was taken from the medical record.
Time frame: Approximately 12 hours after surgery
Number of Subjects With Vomiting
This information was taken from the medical record.
Time frame: Within 20 hours of surgery
Number of Times Antiemetic Rescue Medication Was Used
Time frame: First 24 hours after surgery
Number of Subjects Who Used Antiemetic Rescue Medications
Time frame: First 24 hours after surgery
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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."
Time frame: Approximately 24 hours following surgery