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B&O for TLH Post-operative Pain and Nausea

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ClinicalTrials.gov Identifier: NCT03657407
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Anna Reinert, Mercy Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hysterectomy
Pain, Postoperative
Interventions Drug: Belladonna Opium
Drug: Glycerin Suppository
Enrollment 56
Recruitment Details A cohort of 281 women was assessed for trial eligibility. Patients were excluded from enrollment if the patient could not be reached pre-operatively (n=47), if inclusion criteria were not met (n=67), or if participation was declined (n=106). A cohort of 61 women met criteria for trial enrollment.
Pre-assignment Details From a cohort of 61 women meeting criteria for trial enrollment, individuals were excluded from study participation and randomization if the study protocol was not executed by the surgical team i.e. study medication was not ordered/administrated (n=5). 56 women underwent randomization/assignment to the study interventions.
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Period Title: Overall Study
Started 29 27
Completed 29 27
Not Completed 0 0
Arm/Group Title Belladonna & Opium Placebo Total
Hide Arm/Group Description

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Total of all reporting groups
Overall Number of Baseline Participants 29 27 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 27 participants 56 participants
44.7  (7.9) 41.8  (6.2) 43.1  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Female
29
 100.0%
27
 100.0%
56
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Pain-related indication for surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
18
  62.1%
16
  59.3%
34
  60.7%
[1]
Measure Description: Pre-operative diagnosis of pelvic pain, dysmenorrhea, or dyspareunia
Robotic surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
14
  48.3%
13
  48.1%
27
  48.2%
Laparoscopic surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
15
  51.7%
14
  51.9%
29
  51.8%
Performed by a high-volume surgeon  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
19
  65.5%
16
  59.3%
35
  62.5%
Surgery length  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 29 participants 27 participants 56 participants
97.7  (49.7) 96.0  (49.5) 96.9  (49.2)
Planned admission for 23-hour observation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
8
  27.6%
5
  18.5%
13
  23.2%
Dexamethasone while under anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
29
 100.0%
26
  96.3%
55
  98.2%
Lidocaine while under anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
27
  93.1%
26
  96.3%
53
  94.6%
Ketorolac while under anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
23
  79.3%
25
  92.6%
48
  85.7%
Zofran while under anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
21
  72.4%
19
  70.4%
40
  71.4%
Reglan while under anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
17
  58.6%
16
  59.3%
33
  58.9%
Scopolamine patch pre-operatively  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
1
   3.4%
8
  29.6%
9
  16.1%
1.Primary Outcome
Title Post-operative Pain: VAS
Hide Description Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met
Time Frame up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description:

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.1  (2.9) 4.8  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belladonna & Opium, Placebo
Comments Null hypothesis that Belladonna & Opium not superior to Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.71 to 2.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Narcotic Use
Hide Description Cumulative oral and intravenous narcotics received in PACU until PACU discharge criteria met
Time Frame up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description:

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: Oral Morphine Equivalents in mg
19.3  (14.2) 21.3  (13.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belladonna & Opium, Placebo
Comments Null hypothesis that Belladonna & Opium not superior to Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-5.4 to 9.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time Until Cleared for PACU Discharge
Hide Description Time elapsed from conclusion of surgery until criteria for PACU discharge met
Time Frame up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description:

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: minutes
91.3  (36.7) 110.6  (51.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belladonna & Opium, Placebo
Comments Null hypothesis that Belladonna & Opium not superior to Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -19.31
Confidence Interval (2-Sided) 95%
-43.1 to 4.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants for Which Anti-emetics Were Received in PACU
Hide Description Binary assessment of whether anti-emetics received in PACU
Time Frame up to 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description:

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

Overall Number of Participants Analyzed 29 27
Measure Type: Count of Participants
Unit of Measure: Participants
10
  34.5%
11
  40.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belladonna & Opium, Placebo
Comments Null hypothesis that Belladonna & Opium not superior to Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.42 to 1.7
Estimation Comments [Not Specified]
Time Frame Duration of PACU stay (up to 4 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Belladonna & Opium Placebo
Hide Arm/Group Description

29 women randomized to Belladonna & Opium suppository

Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository

27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository

All-Cause Mortality
Belladonna & Opium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Belladonna & Opium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Belladonna & Opium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/27 (0.00%) 

Study was limited by low power; sample size at 50% of target by power calculations.

Pre-operative scopolamine patch use was not controlled within study randomization, and varied significantly between groups.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anna Reinert, MD
Organization: University of Maryland Medical Center
Phone: 6029089960
EMail: anna.reinert@gmail.com
Layout table for additonal information
Responsible Party: Anna Reinert, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT03657407     History of Changes
Other Study ID Numbers: MMC 2015-63
First Submitted: August 27, 2018
First Posted: September 5, 2018
Results First Submitted: September 6, 2018
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019