Trial Outcomes & Findings for Pre-incision Versus Post-incision Local Anesthetic During Robotic Sacrocolpopexy (NCT NCT04996251)

Results Overview

Difference in Likert-pain scale score difference between pre-incision versus post-incision subcutaneous infiltration with 4-5 milliliters 0.25% Bupivacaine (0 is no pain; 10 is worst pain imaginable)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

129 participants

Primary outcome timeframe

18-24 hours

Results posted on

2024-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Subcutaneous Infiltration Pre-incision Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy	Subcutaneous Infiltration Post-incision local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
Overall Study STARTED	62	67
Overall Study COMPLETED	62	67
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	Subcutaneous Infiltration Pre-incision n=62 Participants Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy	Subcutaneous Infiltration Post-incision n=67 Participants local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy	Total n=129 Participants Total of all reporting groups
Age, Continuous	62 years n=62 Participants	62 years n=67 Participants	62 years n=129 Participants
Sex: Female, Male Female	62 Participants n=62 Participants	67 Participants n=67 Participants	129 Participants n=129 Participants
Sex: Female, Male Male	0 Participants n=62 Participants	0 Participants n=67 Participants	0 Participants n=129 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Total number of patients participating	62 Participants n=62 Participants	67 Participants n=67 Participants	129 Participants n=129 Participants

PRIMARY outcome

Timeframe: 18-24 hours

Difference in Likert-pain scale score difference between pre-incision versus post-incision subcutaneous infiltration with 4-5 milliliters 0.25% Bupivacaine (0 is no pain; 10 is worst pain imaginable)

Outcome measures

Outcome measures
Measure	Subcutaneous Infiltration Pre-incision n=62 Participants Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy	Subcutaneous Infiltration Post-incision n=67 Participants local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
Likert-pain Scale Score on Postoperative Day One	2.94 units on a scale Standard Deviation 2.36	3.27 units on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: 2 weeks

Compare narcotic usage (pills used) until first postoperative appointment

Outcome measures

Outcome measures
Measure	Subcutaneous Infiltration Pre-incision n=62 Participants Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy	Subcutaneous Infiltration Post-incision n=67 Participants local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
Narcotic Usage	0 MME Interval 0.0 to 16.9	0 MME Interval 0.0 to 22.5

Adverse Events

Subcutaneous Infiltration Pre-incision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subcutaneous Infiltration Post-incision

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

Dr. Vini Chopra Konowitz

Northwell Health (previously) now at Advocate Aurora Health

Phone: 859-905-8782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place