Catheter Site DiscomfortNCT02683070
Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention
A study testing Bilateral pudendal nerve block and Intravenous tramadol in people with Catheter Site Discomfort, run by West China Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Catheter Site Discomfort
- What is being tested?
- Bilateral pudendal nerve block and Intravenous tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial
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.
Read the detailed description
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
- Catheter Site Discomfort
- Being tested
- Bilateral pudendal nerve block, Intravenous tramadol
- Keywords
- Catheter-related bladder discomfort, Pudendal nerve block, Tramadol, Randomized controlled trial, catheter-related bladder discomfort prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral pudendal nerve blockProcedure or surgery
Also called Ropivacaine
Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation
Intravenous tramadolDrug
Also called Tramadol
Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation
| Study group | Role | What they receive |
|---|---|---|
| The PNB group | Experimental | Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) will be performed after the completion of surgery before extubation. Receives: Procedure: Bilateral pudendal nerve block |
| The TRAM group | Active comparator | Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation. Receives: Drug: Intravenous tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative CRBD
Patients complained about postoperative CRBD
Measured: 1 day
Secondary outcomes (6)
The severity of postoperative CRBD
It's assessed according to the following scaling system: no CRBD indicates that there are no complaints of CRBD at all; mild indicates that complaints of CRBD exist only if the patient was asked about it; moderate indicates that patients complain of CRBD spontaneously; and severe indicates that CRBD causes a spontaneous behavioral response such as flailing limb, strong vocal response, or attempt to pull out the catheter.
Measured: 1 day
Postoperative tramadol requirement
When moderate or severe CRBD is reported, intravenous tramadol 1.5mg/kg will be administered as a rescue treatment to reduce the bladder discomfort, and tramadol requirement will be recorded and compared.
Measured: 1 day
Numeric rating scale (NRS) for postoperative pain.
Patients will be asked for evaluating pain intensity by themselves using this single 11-point numeric scale ranged between 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain" [17]. If the patient complains about pain with NRS greater than 4, intravenous sufentanil 5 μg will be administered as rescue analgetic treatment.
Measured: 1 day
Postoperative sufentanil requirement
Intravenous sufentanil 5 μg will be administered as rescue analgetic treatment for postoperative pain, and sufentanil requirementwill be recorded and compared.
Measured: 1 day
Incidences of postoperative side effects
Side effects include postoperative nausea/vomiting (PONV), dizziness, sedation, and dry mouth.
Measured: 1 day
Acceptance of indwelling urinary catheter after extraction of the catheter
Patients will be asked to answer the question "Will you worry about urinary catheterization if you undergo another operation next time?". The answer "No" meant acceptance of indwelling urinary catheter, and the answer "Yes" meant unacceptance of indwelling urinary catheter.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter Site DiscomfortStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683070
- Sponsor's protocol ID
- PNB2015-306
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: It is undecided whether to share IPD
Publications
Li JY, Liao R. Prevention of catheter-related bladder discomfort - pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial. Trials. 2016 Sep 13;17(1):448. doi: 10.1186/s13063-016-1575-y.
PubMed 27618967
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02683070
- Acronym / sponsor ID
- PNB2015-306
- Conditions
- Catheter Site Discomfort
- Keywords
- Catheter-related bladder discomfort, Pudendal nerve block, Tramadol, Randomized controlled trial, catheter-related bladder discomfort prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The PNB group | Experimental | Procedure: Bilateral pudendal nerve blockBilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) will be performed after the completion of surgery before extubation. |
| The TRAM group | Active comparator | Drug: Intravenous tramadolIntravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral pudendal nerve blockAlso: RopivacaineBilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation | Procedure or surgery | The PNB group |
| Intravenous tramadolAlso: TramadolIntravenous tramadol of 1.5mg/kg after the completion of surgery before extubation | Drug | The TRAM group |
Primary outcome
The incidence of postoperative CRBD
Time frame: 1 day
Patients complained about postoperative CRBD
6 secondary outcomes
The severity of postoperative CRBD
Time frame: 1 day
Postoperative tramadol requirement
Time frame: 1 day
Numeric rating scale (NRS) for postoperative pain.
Time frame: 1 day
Postoperative sufentanil requirement
Time frame: 1 day
Incidences of postoperative side effects
Time frame: 1 day
Acceptance of indwelling urinary catheter after extraction of the catheter
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 27618967Li JY, Liao R. Prevention of catheter-related bladder discomfort - pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial. Trials. 2016 Sep 13;17(1):448. doi: 10.1186/s13063-016-1575-y.
- Individual participant dataSharing planned: Undecided. It is undecided whether to share IPD
Related trials for Catheter Site Discomfort
Recruiting
Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
Prostate Cancer (Post Prostatectomy), Perioperative Anesthetic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ren Liao, M.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral pudendal nerve block and Intravenous tramadol in people with Catheter Site Discomfort, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ren Liao, M.D. (+86-18980602177, liaoren7733@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative CRBD (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.