Trial Outcomes & Findings for Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (NCT NCT02517996)
NCT ID: NCT02517996
Last Updated: 2019-07-24
Results Overview
To determine the change in pain at 2 hours, 2 weeks, 6 weeks, and 3 months postoperatively in patients undergoing hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline) using the visual analog scale (VAS). VAS consists of a 10cm horizontal line with the minimum endpoint labeled "no pain" (0) and maximum labeled "worst pain ever" (10). Patients placed a mark on the point that corresponds to the level of pain severity they felt. The cm distance from the low end of the VAS to the patient's mark is used as the numerical index of the intensity of pain. Pain scores of 3.0-5.4 cm are moderate, over 5.4 indicates severe pain.
TERMINATED
NA
18 participants
Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)
2019-07-24
Participant Flow
Patients for this study are recruited either directly from the clinic of a Urogyn attending, or are identified the week before surgery on the OR schedule. The patients eligible for this study need to be posted for cystoscopy with hydrodistention for a diagnosis of bladder pain.
1 woman was unmasked after her initial postoperative scores were collected because of postoperative symptoms.
Participant milestones
| Measure |
1% Lidocaine
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the postsynaptic neuron membrane will not depolarize and so fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Baseline characteristics by cohort
| Measure |
1% Lidocaine
n=8 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the postsynaptic neuron membrane will not depolarize and so fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
n=9 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
Total
n=17 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.1 years
n=5 Participants
|
39.7 years
n=7 Participants
|
40.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Previous procedure
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of other therapies
|
3 Number of other therapies
n=5 Participants
|
3 Number of other therapies
n=7 Participants
|
3 Number of other therapies
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)Population: Loss to follow up of 2 participants in the Normal Saline group
To determine the change in pain at 2 hours, 2 weeks, 6 weeks, and 3 months postoperatively in patients undergoing hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline) using the visual analog scale (VAS). VAS consists of a 10cm horizontal line with the minimum endpoint labeled "no pain" (0) and maximum labeled "worst pain ever" (10). Patients placed a mark on the point that corresponds to the level of pain severity they felt. The cm distance from the low end of the VAS to the patient's mark is used as the numerical index of the intensity of pain. Pain scores of 3.0-5.4 cm are moderate, over 5.4 indicates severe pain.
Outcome measures
| Measure |
1% Lidocaine
n=8 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by stopping pain signals from propagating to the brain before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
n=9 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
|---|---|---|
|
Change in Pain Level as Assessed by the Visual Analog Scale (VAS)
Pre operative VAS score
|
3.125 score on a scale
Standard Deviation 2.59
|
4.5 score on a scale
Standard Deviation 2.5
|
|
Change in Pain Level as Assessed by the Visual Analog Scale (VAS)
Post operative VAS score
|
3.75 score on a scale
Standard Deviation 2.43
|
5 score on a scale
Standard Deviation 1.73
|
|
Change in Pain Level as Assessed by the Visual Analog Scale (VAS)
2 week post operative VAS scores
|
2.7 score on a scale
Standard Deviation 2.68
|
4.8 score on a scale
Standard Deviation 1.30
|
|
Change in Pain Level as Assessed by the Visual Analog Scale (VAS)
6 week post operative VAS score
|
3 score on a scale
Standard Deviation 3.31
|
4.33 score on a scale
Standard Deviation 2.1
|
|
Change in Pain Level as Assessed by the Visual Analog Scale (VAS)
12 weeks post operative VAS score
|
2.6 score on a scale
Standard Deviation 2.4
|
2 score on a scale
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 3 months (Up to 3 months)Population: Loss to follow up of 2 participants in the Normal Saline group
To determine the change in interstitial cystitis symptom index at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline). The IC symptom index questionnaire consists of 4 questions on IC symptoms. 2 of the questions have 6 answer choices ranging from 0-never, to 5-almost always. 1 question has 6 answer choices ranging from 0-never to 5-usually. 1 question has 7 answer choices ranging from 0-never to 6-5 or more times. The numerical score for each question are added together, with a minimum score of 0 and a maximum score of 21. A higher score indicates greater severity of IC symptoms.
Outcome measures
| Measure |
1% Lidocaine
n=8 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by stopping pain signals from propagating to the brain before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
n=9 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
|---|---|---|
|
Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
Baseline
|
12.5 score on a scale
Standard Deviation 3.74
|
10 score on a scale
Standard Deviation 2.52
|
|
Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
6 weeks
|
11.8 score on a scale
Standard Deviation 3.83
|
8.67 score on a scale
Standard Deviation 4.62
|
|
Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
2 weeks
|
11.43 score on a scale
Standard Deviation 4.72
|
9 score on a scale
Standard Deviation 3.16
|
|
Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
12 weeks
|
10 score on a scale
Standard Deviation 3.94
|
5 score on a scale
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)Population: Loss to follow up of 2 participants in the Normal Saline group
To determine the change in problem index (O'Leary Sant) at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline). The IC problem index questionnaire consists of 4 questions on how much of a problem a patient's IC symptoms cause them. Each question has 5 answer choices ranging from 0-no problem, to 4-big problem. The numerical score for each question are added together, with a minimum score of 0 and a maximum score of 16. A higher score indicates that IC symptoms cause more problems for the patient.
Outcome measures
| Measure |
1% Lidocaine
n=8 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by stopping pain signals from propagating to the brain before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
n=9 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
|---|---|---|
|
Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline
12 weeks
|
9.6 score on a scale
Standard Deviation 2.79
|
6 score on a scale
Standard Deviation 2.83
|
|
Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline
Baseline
|
11.75 score on a scale
Standard Deviation 2.92
|
9.43 score on a scale
Standard Deviation 3.10
|
|
Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline
2 weeks
|
9.71 score on a scale
Standard Deviation 3.95
|
8.6 score on a scale
Standard Deviation 2.07
|
|
Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline
6 weeks
|
10 score on a scale
Standard Deviation 3.81
|
7.33 score on a scale
Standard Deviation 3.21
|
PRIMARY outcome
Timeframe: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)Population: Loss to follow up of 3 participants in the Normal Saline group
To determine the change in pelvic urgency, pain and frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline). The Pelvic Urgency, Pain, and Frequency Patient Symptom Scale asks 11 questions, 7 on PUF symptoms, 4 on how bothersome PUF symptoms are. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always. The symptom score is added, the bother score is added, and then the total score is added. The total PUF score is then reported. The minimum score is 0 and the maximum score is 35, and a higher score indicates greater symptoms and higher bother from pelvic pain and frequency.
Outcome measures
| Measure |
1% Lidocaine
n=8 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Lidocaine: Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by stopping pain signals from propagating to the brain before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
|
Normal Saline
n=9 Participants
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Placebo: Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
|
|---|---|---|
|
Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
6 weeks
|
18.2 score on a scale
Standard Deviation 7.53
|
16.7 score on a scale
Standard Deviation 3.21
|
|
Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
Baseline
|
22.63 score on a scale
Standard Deviation 6.74
|
19 score on a scale
Standard Deviation 4
|
|
Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
2 weeks
|
18.83 score on a scale
Standard Deviation 7.99
|
17.4 score on a scale
Standard Deviation 4.72
|
|
Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline
12 weeks
|
17.2 score on a scale
Standard Deviation 6.61
|
14 score on a scale
Standard Deviation NA
1 participant
|
Adverse Events
1% Lidocaine
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tola Fashokun
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place