Catheter Site DiscomfortNCT03199105
Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD
A study testing Preoperative education with image illustrations and/or local tetracaine mucilage 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 colonal and rectal surgery with surgical duration of at least 2 h… 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?
- Preoperative education with image illustrations and/or local tetracaine mucilage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 20 Oct 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 18 years to 75 years.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.
- 5.Duration of surgery more than 2h 6.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.
Show all 12Show fewer
- 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.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Chunling Jiang, Doctor, 18980601096, jiang_chunling@yahoo.com
About this study
Official title: Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study
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 colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.
- Conditions
- Catheter Site Discomfort
- Being tested
- Preoperative education with image illustrations and/or local tetracaine mucilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative education with image illustrations and/or local tetracaine mucilageOther
The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.
| Study group | Role | What they receive |
|---|---|---|
| preoperative education and tetracaine | Experimental | Not described Receives: Other: Preoperative education with image illustrations and/or local tetracaine mucilage |
| tetracaine | Experimental | Not described Receives: Other: Preoperative education with image illustrations and/or local tetracaine mucilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative CRBD
The incidence of postoperative CRBD; CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)
Measured: 6 hours
Secondary outcomes (5)
The severity of postoperative CRBD
The severity of CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)
Measured: 6 hours
The incidence of emergence agitation
Using Riker Sedation-Agitation Scale, where 5 to 7 represents agitation and 1 to 3 represents deep sedation
Measured: 6 hours
The incidence of postoperative pain
The incidence of postoperative pain;Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.
Measured: 6 hours
The severity of postoperative pain
Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.
Measured: 6 hours
Incidenc of adverse events
Incidenc of adverse events, such asrespiratory depression (SpO2<90%), deep sedation, and toxicity of tetracaine
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jul 2017
- Primary completion20 Oct 2018 (estimated)
- Study completion20 Oct 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199105
- Sponsor's protocol ID
- 2014-159
- Status last verified
- Jun 2018
- First submitted
- 22 Jun 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou L, Zhou L, Tian L, Zhu D, Chen Z, Zheng C, Zhou T, Zeng X, Jiang X, Jiang C, Bo L. Preoperative education with image illustrations enhances the effect of tetracaine mucilage in alleviating postoperative catheter-related bladder discomfort: a prospective, randomized, controlled study. BMC Anesthesiol. 2018 Dec 22;18(1):204. doi: 10.1186/s12871-018-0653-y.
PubMed 30579342
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03199105
- Acronym / sponsor ID
- 2014-159
- Conditions
- Catheter Site Discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Oct 2018 (estimated)
- Study completion
- 20 Oct 2018 (estimated)
- First posted
- 26 Jun 2017 (actual)
- 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 colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative education and tetracaine | Experimental | Other: Preoperative education with image illustrations and/or local tetracaine mucilage |
| tetracaine | Experimental | Other: Preoperative education with image illustrations and/or local tetracaine mucilage |
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 18 years to 75 years.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.
- 5.Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of 15. Ability to communicate.
Key exclusion criteria (12 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 |
|---|---|---|
| Preoperative education with image illustrations and/or local tetracaine mucilageThe patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period. | Other | preoperative education and tetracaine, tetracaine |
Primary outcome
The incidence of postoperative CRBD
Time frame: 6 hours
The incidence of postoperative CRBD; CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)
5 secondary outcomes
The severity of postoperative CRBD
Time frame: 6 hours
The incidence of emergence agitation
Time frame: 6 hours
The incidence of postoperative pain
Time frame: 6 hours
The severity of postoperative pain
Time frame: 6 hours
Incidenc of adverse events
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Derived from this study: PubMed 30579342Zhou L, Zhou L, Tian L, Zhu D, Chen Z, Zheng C, Zhou T, Zeng X, Jiang X, Jiang C, Bo L. Preoperative education with image illustrations enhances the effect of tetracaine mucilage in alleviating postoperative catheter-related bladder discomfort: a prospective, randomized, controlled study. BMC Anesthesiol. 2018 Dec 22;18(1):204. doi: 10.1186/s12871-018-0653-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative education with image illustrations and/or local tetracaine mucilage 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 12 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 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative CRBD (time frame: 6 hours). 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 NCT03199105, 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 Aug 2018.