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CompletedNCT01150474Updated Jan 7, 2015Results posted

Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

A Phase 4 interventional study of Belladonna and Opium Suppositories and Placebo Suppositories in Vaginal Surgery, sponsored by Kristina A. Butler. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-07.

Sponsored by Kristina A. Butler · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Vaginal Surgery

Keywords

  • Belladonna
  • Morphine
  • Suppositories
  • Vaginal
  • Surgery
  • Postoperative
  • Pain
03

In context

Lead sponsor

This is the only study on the registry with Kristina A. Butler as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.

Exclusion criteria

Exclusion Criteria:

  • Participation in another trial using an investigational product.
  • Pregnancy.
  • Scheduled for a non-vaginal surgical procedure.
  • Scheduled for a robotic hysterectomy.
  • Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
  • There is a known hypersensitivity to belladonna and/or opium.
  • Contraindication to narcotic use.
  • Chronic pain with preoperative pain score greater than 4 out of 10 points.
  • Clinically significant substance abuse.
  • Mental condition that may impair the ability to provide study assessments.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Belladonna and Opium Suppositories

  • Placebo comparator
    Placebo Suppositories

    Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

    Drug: Placebo Suppositories

Interventions

  • DrugBelladonna 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.

    Also known as: B & O Supprettes

  • DrugPlacebo Suppositories

    Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Narcotic Rescue Medication

    Use of all ancillary narcotic medications was taken from the medical record.

    Time frame: For 24 hours following surgery

  4. Number of Subjects With Nausea

    This information was taken from the medical record.

    Time frame: Approximately 12 hours after surgery

  5. Number of Subjects With Vomiting

    This information was taken from the medical record.

    Time frame: Within 20 hours of surgery

  6. Number of Times Antiemetic Rescue Medication Was Used

    Time frame: First 24 hours after surgery

  7. Number of Subjects Who Used Antiemetic Rescue Medications

    Time frame: First 24 hours after surgery

  8. 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

07

Results

Posted Jan 7, 2015

Participant flow

Subjects were recruited at the Mayo Clinic in Arizona, United States from January 2011 to April 2013.

Participant flow — Overall Study
MilestoneBelladonna and Opium SuppositoriesPlacebo Suppositories
Started5152
Completed4149
Not completed103
Withdrew: Withdrawal by subject52
Withdrew: Cancer found10
Withdrew: Multiple studies01
Withdrew: Rectotomy10
Withdrew: Drug did not arrive in time10
Withdrew: Drug not administered10
Withdrew: Surgery changed10

Outcome measures

PrimaryPain 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
Reported as:
Mean · units on a scale
Pain at Hour 4
units on a scaleBelladonna and Opium SuppositoriesPlacebo Suppositories
Pain at Hour 44.2 ± 2.44.1 ± 2.1
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.82
SecondaryPain 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.
Reported as:
Mean · units on a scale
Pain at Hour 12
units on a scaleBelladonna and Opium SuppositoriesPlacebo Suppositories
Pain at Hour 123.4 ± 2.43.3 ± 2.2
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.75
SecondaryPain 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.
Reported as:
Mean · units on a scale
Pain at Hour 20
units on a scaleBelladonna and Opium SuppositoriesPlacebo Suppositories
Pain at Hour 202.5 ± 1.93.4 ± 2.5
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.07
SecondaryNarcotic Rescue Medication

Use of all ancillary narcotic medications was taken from the medical record.

Time frame:
For 24 hours following surgery
Reported as:
Mean · mg IV morphine equivalents
Narcotic Rescue Medication
mg IV morphine equivalentsBelladonna and Opium SuppositoriesPlacebo Suppositories
Narcotic Rescue Medication57 ± 3866 ± 61
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.43
SecondaryNumber of Subjects With Nausea

This information was taken from the medical record.

Time frame:
Approximately 12 hours after surgery
Reported as:
Number · participants
Number of Subjects With Nausea
participantsBelladonna and Opium SuppositoriesPlacebo Suppositories
Number of Subjects With Nausea1422
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.30
SecondaryNumber of Subjects With Vomiting

This information was taken from the medical record.

Time frame:
Within 20 hours of surgery
Reported as:
Number · participants
Number of Subjects With Vomiting
participantsBelladonna and Opium SuppositoriesPlacebo Suppositories
Number of Subjects With Vomiting139
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.14
SecondaryNumber of Times Antiemetic Rescue Medication Was Used
Time frame:
First 24 hours after surgery
Reported as:
Mean · number of times antiemetics used
Number of Times Antiemetic Rescue Medication Was Used
number of times antiemetics usedBelladonna and Opium SuppositoriesPlacebo Suppositories
Number of Times Antiemetic Rescue Medication Was Used1.7 ± 1.61.6 ± 1.5
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.83
SecondaryNumber of Subjects Who Used Antiemetic Rescue Medications
Time frame:
First 24 hours after surgery
Reported as:
Number · participants
Number of Subjects Who Used Antiemetic Rescue Medications
participantsBelladonna and Opium SuppositoriesPlacebo Suppositories
Number of Subjects Who Used Antiemetic Rescue Medications3033
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.55
SecondarySatisfaction 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
Reported as:
Mean · units on a scale
Satisfaction With Pain Relief
units on a scaleBelladonna and Opium SuppositoriesPlacebo Suppositories
Satisfaction With Pain Relief8.2 ± 2.57.9 ± 2.6
Statistical analysis
  • Belladonna and Opium Suppositories vs Placebo Suppositories · t-test, 2 sided · p = 0.59

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Belladonna and Opium Suppositories—1/41 (2.4%)24/41 (58.5%)
Placebo Suppositories—0/49 (0%)27/49 (55.1%)
Most frequent serious events
Most frequent serious events
EventBelladonna and Opium SuppositoriesPlacebo Suppositories
Abdominal SepsisGeneral disorders1/410/49
Most frequent other events
Most frequent other events
EventBelladonna and Opium SuppositoriesPlacebo Suppositories
ConstipationGastrointestinal disorders20/3527/46
Urinary RetentionRenal and urinary disorders21/4123/49
Anemia PostoperativeBlood and lymphatic system disorders3/410/49
Procedural HypotensionCardiac disorders1/413/49
Postoperative IleusGastrointestinal disorders1/410/49
Procedural HypertensionCardiac disorders1/410/49
Pruritis GeneralizedSkin and subcutaneous tissue disorders1/410/49
Sinus TachycardiaCardiac disorders1/410/49
Urinary Tract InfectionRenal and urinary disorders1/410/49
Sleep Apnea SyndromeRespiratory, thoracic and mediastinal disorders0/411/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Mean56 ± 1255 ± 1355 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Female414990
Male000
Region of Enrollment
Region of Enrollment(participants)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
United States414990
Pelvic Organ Prolapse
Pelvic Organ Prolapse(participants)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Prolapse212546
No Prolapse202444
Procedure time
Procedure time(minutes)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Mean98 ± 3796 ± 3897 ± 37
Estimated Blood Loss
Estimated Blood Loss(mL)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Mean180 ± 250150 ± 110161 ± 186
Preoperative Pain
Preoperative Pain(units on a scale)Belladonna and Opium SuppositoriesPlacebo SuppositoriesTotal
Mean0.44 ± 1.250.24 ± 0.910.3 ± 1.07
08

Study locations

1 site
  • Mayo Clinic
    Phoenix, Arizona 85054, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01150474
Lead sponsor
Kristina A. Butler
Responsible party
Kristina A. Butler (M.D., Mayo Clinic) — Sponsor-investigator
First posted
Jun 25, 2010
Start date
Jan 2011
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Jan 7, 2015
Last update
Jan 7, 2015

Study contacts

Kristina Butler, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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