Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective prostate surgery with urinary catheterization after anesthetic induction, and compare the efficacy of pudendal nerve block (PNB) and intravenous tramadol in prevention of CRBD.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DPNB for Prevention of CRDB

NCT01721031

Indwelling Urinary Catheter Male Patients General Anesthesia

COMPLETED PHASE3

Preventing Catheter Related Bladder Discomfort (CRBD) With Bilateral Pudendal Nerve Block

NCT05022160

Bladder Neoplasm Prostatic Neoplasms

UNKNOWN EARLY_PHASE1

Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

NCT05957653

Prostate Cancer

UNKNOWN PHASE4

Use of Perioperative Pain Blocks In Urological Surgery

NCT04426500

Pain, Postoperative Nerve Block Robotic Surgical Procedures

COMPLETED PHASE3

Pudendal Nerve Block in Vaginal Surgery

NCT04198714

Nerve Block Pain, Postoperative Pelvic Floor Disorders +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The PNB trial is an investigator-initiated, prospective, randomized controlled trial that will test the superiority of pudendal nerve block with 0.33% ropivacaine to intravenous tramadol 1.5mg/kg for CRBD prevention. A total of 94 patients undergoing elective prostate surgery at lithotomy position with urinary catheterization (16 G Fr Foley catheter) after anesthetic induction under general anesthesia will be enrolled at West China Hospital of Sichuan University. Patients will be divided randomly into two groups:

The PNB group: patients will be given bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation.

The TRAM group: patients will be given tramadol of 1.5mg/kg after the completion of surgery before extubation.

All patients will be evaluated by a research nurse who were blinded to the group assignments for outcomes at 0, 1, 2, 4, and 6h after patients' arrival in PACU, and after extraction of urinary catheter.

The primary outcome is the incidence of postoperative CRBD. The secondary outcomes include the severity of postoperative CRBD, postoperative tramadol requirement and number of patients with requiring postoperative tramadol, numeric rating scale (NRS) for postoperative pain, postoperative sufentanil requirement and number of patients with requiring postoperative sufentanil, postoperative side effects, and acceptance of indwelling urinary catheter after extraction of the catheter.

All primary and secondary endpoints will be analyzed on an intent-to-treat basis. Analyses are performed with the use of SPSS 18.0 software. The Student-t test is used to analyze demographic data in the two groups. The incidence of CRBD and side effects between groups are analyzed by Chi-square test, whereas the severity of CRBD (mild, moderate, and severe) is analyzed by Fisher's exact test. NRS scale is analyzed by the Mann-Whitney test. Postoperative tramadol and sufentanil requirement is analyzed by Z test, and the number of patients requiring tramadol for CRBD rescue treatment and sufentanil for postoperative pain will be analyzed with Fisher's exact test. A P value\<0.05 is considered significant.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Catheter Site Discomfort

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The PNB group

Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) will be performed after the completion of surgery before extubation.

Group Type EXPERIMENTAL

Bilateral pudendal nerve block

Intervention Type PROCEDURE

Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation

The TRAM group

Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation.

Group Type ACTIVE_COMPARATOR

Intravenous tramadol

Intervention Type DRUG

Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilateral pudendal nerve block

Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation

Intervention Type PROCEDURE

Intravenous tramadol

Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ropivacaine Tramadol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18years to 75years.
* American Society of Anesthesiologists (ASA) physical status I, II, or Ⅲ.
* Undergoing elective prostate surgery at lithotomy position with urinary catheterization after anesthetic induction under general anesthesia.
* Glasgow Coma Scale (GCS) score of 15. Ability to communicate.

Exclusion Criteria

* History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
* History of bladder outflow obstruction.
* Neurogenic bladder.
* Impaired renal function.
* Coagulopathy.
* Known allergies to any anesthetic agent.
* Family history of malignant hyperthermia.
* Impairment of communication or cognition.
* Psychopathy.
* Active participation in another trial where the primary endpoint follow-up is ongoing.
* Unwillingness or inability to comply with protocol procedures.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No