Trial Outcomes & Findings for Randomized Control Trial to Assess Postoperative Pain After Sling Placement (NCT NCT00746863)

NCT ID: NCT00746863

Last Updated: 2010-06-22

Results Overview

At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 2 hours postoperative from mid-urethral sling placement
• Results posted on: 2010-06-22

Participant Flow

From January 2008 to September of 2009, all female patients planning to undergo a sling with or without an anterior or posterior repair at the University of North Carolina (UNC) Hospital were approached for participation.

Participant milestones

Measure	Intervention Group - Received Marcaine Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Control Trial to Assess Postoperative Pain After Sling Placement

Baseline characteristics by cohort

Measure	Intervention Group - Received Marcaine n=21 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	49.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	52.6 years STANDARD_DEVIATION 10.7 • n=7 Participants	52 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours postoperative from mid-urethral sling placement

Population: Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.

At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

Outcome measures

Measure	Intervention Group - Received Marcaine n=20 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.	1.9 cm Standard Deviation 2.38	2.6 cm Standard Deviation 1.78

PRIMARY outcome

Timeframe: 6 hours postoperative from mid-urethral sling placement

Population: Intention to treat

At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

Outcome measures

Measure	Intervention Group - Received Marcaine n=21 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.	2.1 cm Standard Deviation 2.46	2.3 cm Standard Deviation 2.0

PRIMARY outcome

Timeframe: 24 hours postoperative from mid-urethral sling placement

Population: Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.

At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

Outcome measures

Measure	Intervention Group - Received Marcaine n=21 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=20 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.	2.0 cm Standard Deviation 2.37	2.3 cm Standard Deviation 2.22

SECONDARY outcome

Timeframe: From surgery until discharge, average

Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.

Outcome measures

Measure	Intervention Group - Received Marcaine n=21 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
In-hospital Medication Amounts	4 number of pills Standard Deviation 3.83	6 number of pills Standard Deviation 4.32

SECONDARY outcome

Timeframe: From after surgery to discharge from hospital.

Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.

Outcome measures

Measure	Intervention Group - Received Marcaine n=21 Participants Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 Participants Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.	4 participants w/sucessful voiding trial	7 participants w/sucessful voiding trial

Adverse Events

Intervention Group - Received Marcaine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Group - No Marcaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Group - Received Marcaine n=21 participants at risk Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.	Control Group - No Marcaine n=21 participants at risk Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
Surgical and medical procedures Blood transfusion	4.8% 1/21 • Number of events 1 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.	0.00% 0/21 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.
Surgical and medical procedures Labial hematoma	4.8% 1/21 • Number of events 1 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.	0.00% 0/21 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.
Surgical and medical procedures Hip pain	4.8% 1/21 • Number of events 1 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.	0.00% 0/21 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.
Renal and urinary disorders Prolonged voiding dysfunction	0.00% 0/21 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.	4.8% 1/21 • Number of events 1 • From time of surgery to 6 weeks after surgery A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.

Additional Information

Gena Dunivan, MD

UNC Hospitals

Phone: 919-966-4717

Email: gdunivan@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place