Trial Outcomes & Findings for Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain. (NCT NCT03027661)

Last Updated: 2018-11-15

Results Overview

Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

30 minutes post-operative stop time

Results posted on

2018-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock 0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma	Study Group Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock. Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma
Overall Study STARTED	20	21
Overall Study COMPLETED	20	21
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	Control Group n=20 Participants Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock 0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma	Study Group n=21 Participants Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock. Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	21 Participants n=21 Participants	41 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=41 Participants
Age, Continuous	46.50 years STANDARD_DEVIATION 9.8 • n=20 Participants	46 years STANDARD_DEVIATION 10.4 • n=21 Participants	46.24 years STANDARD_DEVIATION 10.0 • n=41 Participants
Sex: Female, Male Female	20 Participants n=20 Participants	21 Participants n=21 Participants	41 Participants n=41 Participants
Sex: Female, Male Male	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=41 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	21 participants n=21 Participants	41 participants n=41 Participants
BMI	35.05 kg/m^2 STANDARD_DEVIATION 9.8 • n=20 Participants	32.75 kg/m^2 STANDARD_DEVIATION 9.8 • n=21 Participants	33.87 kg/m^2 STANDARD_DEVIATION 9.7 • n=41 Participants
history of csection	11 Participants n=20 Participants	8 Participants n=21 Participants	19 Participants n=41 Participants

PRIMARY outcome

Timeframe: 30 minutes post-operative stop time

Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock 0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma	Study Group n=21 Participants Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock. Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma
Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative	5.7 VAS scale 0-10 Standard Deviation 2.8	3.2 VAS scale 0-10 Standard Deviation 3.4

PRIMARY outcome

Timeframe: 60 minutes

Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock 0.9% Sodium Chloride: Inject 10 mL of 0.9% NaCl into cervical stroma	Study Group n=21 Participants Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock. Bupivacaine: Inject 10 mL of 0.5% bupivacaine into cervical stroma
Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative	5.9 VAS scale 0-10 Standard Deviation 3.0	2.3 VAS scale 0-10 Standard Deviation 2.8

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Group

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

Elaine Todd, Director of Sponsored Programs - Contracts and research agreements

University of Tennessee Health and Science Center

Phone: 9014483303

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place