Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

NCT02517996 | Terminated Results DMC

• 1 other identifier: IRB00034476
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its public health importance the pathogenesis of IC/PBS is not well understood and there is no consensus on the optimal treatment approach for this condition. Hydrodistention is the most commonly used therapy for this condition; but it is limited by severe immediate postoperative bladder pain and its short duration of action. It has been postulated that hydrodistention works by disrupting the sensory nerves within the bladder that may be contributing to bladder pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in lower postoperative pain after hydrodistention compared to placebo. This is a prospective double- blinded randomized study and patients will be randomized to receive preemptive bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Outcome Measures

Primary Outcomes (4)

• Change in Pain Level as Assessed by the Visual Analog Scale (VAS)

  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.

  Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)

• Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline

  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.

  Baseline, 2 weeks, 6 weeks, 3 months (Up to 3 months)

• Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline

  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.

  Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)

• Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline

  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.

  Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)

Study Arms (2)

1% Lidocaine

EXPERIMENTAL

Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.

Drug: Lidocaine

Normal Saline

PLACEBO COMPARATOR

Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.

Drug: Placebo

Interventions

Lidocaine DRUG

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 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.

1% Lidocaine

Placebo DRUG

Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women aged greater than 18 years of age scheduled to undergo cystoscopy with hydrodistention
• who are literate,
• English speaking and
• can provide written informed consent will be included in this study.

You may not qualify if:

• Patients who have intolerance or known allergies to local analgesia will be excluded.
• In addition, patients who have coagulation disorders will also be excluded as this may increase their risks of complication from bleeding.
• Patient will also be excluded if they have a history of dementia as this may impair their ability to follow instructions.
• Patients who are non-ambulatory and who have an inability to fully assess pain will also be excluded.
• Patients receiving additional surgical procedures will be excluded from the study, as the source of their pain may be difficult to decipher in the immediate post-operative period.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Many potential participants noted that they were unwilling to enroll due to fear of being randomized to the saline arm.

Results Point of Contact

• Title: Dr. Tola Fashokun
• Organization: Johns Hopkins University School of Medicine

bunmi_omo@hotmail.com

410-464-6641

Study Officials

• Tola Fashokun, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: August 7, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 24, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-07

Locations

US (2)