Trial Outcomes & Findings for B&O for TLH Post-operative Pain and Nausea (NCT NCT03657407)

Last Updated: 2019-04-02

Results Overview

Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

up to 4 hours

Results posted on

2019-04-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Belladonna & Opium 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository
Overall Study STARTED	29	27
Overall Study COMPLETED	29	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belladonna & Opium n=29 Participants 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo n=27 Participants 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository	Total n=56 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 7.9 • n=29 Participants	41.8 years STANDARD_DEVIATION 6.2 • n=27 Participants	43.1 years STANDARD_DEVIATION 7.4 • n=56 Participants
Sex: Female, Male Female	29 Participants n=29 Participants	27 Participants n=27 Participants	56 Participants n=56 Participants
Sex: Female, Male Male	0 Participants n=29 Participants	0 Participants n=27 Participants	0 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Pain-related indication for surgery	18 Participants n=29 Participants	16 Participants n=27 Participants	34 Participants n=56 Participants
Robotic surgery	14 Participants n=29 Participants	13 Participants n=27 Participants	27 Participants n=56 Participants
Laparoscopic surgery	15 Participants n=29 Participants	14 Participants n=27 Participants	29 Participants n=56 Participants
Performed by a high-volume surgeon	19 Participants n=29 Participants	16 Participants n=27 Participants	35 Participants n=56 Participants
Surgery length	97.7 minutes STANDARD_DEVIATION 49.7 • n=29 Participants	96.0 minutes STANDARD_DEVIATION 49.5 • n=27 Participants	96.9 minutes STANDARD_DEVIATION 49.2 • n=56 Participants
Planned admission for 23-hour observation	8 Participants n=29 Participants	5 Participants n=27 Participants	13 Participants n=56 Participants
Dexamethasone while under anesthesia	29 Participants n=29 Participants	26 Participants n=27 Participants	55 Participants n=56 Participants
Lidocaine while under anesthesia	27 Participants n=29 Participants	26 Participants n=27 Participants	53 Participants n=56 Participants
Ketorolac while under anesthesia	23 Participants n=29 Participants	25 Participants n=27 Participants	48 Participants n=56 Participants
Zofran while under anesthesia	21 Participants n=29 Participants	19 Participants n=27 Participants	40 Participants n=56 Participants
Reglan while under anesthesia	17 Participants n=29 Participants	16 Participants n=27 Participants	33 Participants n=56 Participants
Scopolamine patch pre-operatively	1 Participants n=29 Participants	8 Participants n=27 Participants	9 Participants n=56 Participants

PRIMARY outcome

Timeframe: up to 4 hours

Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met

Outcome measures

Outcome measures
Measure	Belladonna & Opium n=29 Participants 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo n=27 Participants 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository
Post-operative Pain: VAS	4.1 score on a scale Standard Deviation 2.9	4.8 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: up to 4 hours

Cumulative oral and intravenous narcotics received in PACU until PACU discharge criteria met

Outcome measures

Outcome measures
Measure	Belladonna & Opium n=29 Participants 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo n=27 Participants 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository
Narcotic Use	19.3 Oral Morphine Equivalents in mg Standard Deviation 14.2	21.3 Oral Morphine Equivalents in mg Standard Deviation 13.5

SECONDARY outcome

Timeframe: up to 4 hours

Time elapsed from conclusion of surgery until criteria for PACU discharge met

Outcome measures

Outcome measures
Measure	Belladonna & Opium n=29 Participants 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo n=27 Participants 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository
Time Until Cleared for PACU Discharge	91.3 minutes Standard Deviation 36.7	110.6 minutes Standard Deviation 51.4

SECONDARY outcome

Timeframe: up to 4 hours

Binary assessment of whether anti-emetics received in PACU

Outcome measures

Outcome measures
Measure	Belladonna & Opium n=29 Participants 29 women randomized to Belladonna \& Opium suppository Belladonna Opium: Belladonna Opium 16.2-60mg rectal suppository	Placebo n=27 Participants 27 women randomized to Glycerin suppository Glycerin Suppository: Glycerine rectal suppository
Number of Participants for Which Anti-emetics Were Received in PACU	10 Participants	11 Participants

Adverse Events

Belladonna & Opium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Reinert, MD

University of Maryland Medical Center

Phone: 6029089960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place