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a prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.
The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean section may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with an indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD.
More preventive than therapeutic drugs for CRBD should be investigated to improve patient comfort in all surgery patients with a urinary catheter.
A prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyoscine-n-butylbromide group | Experimental | one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section. |
|
| control group | Placebo Comparator | the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyoscine-n-butylbromide | Drug | one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section. |
| Measure | Description | Time Frame |
|---|---|---|
| catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS). | the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). CRBD will be defined as the presence of an urge to void or suprapubic discomfort with an NRS score of ≥3. | one hour post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS). | the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). |
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Inclusion Criteria:
Exclusion Criteria:
• Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks).
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| Name | Affiliation | Role |
|---|---|---|
| AHMED SAMY, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Ashour | Giza | 12944 | Egypt |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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A prospective randomized clinical trial
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| control group | Drug | an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section. |
|
|
| two hours postopeatively. |
| catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS). | numerical rating scale. | six hours postoperatively. |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting | 6 hours postoperative |
| dry mouth | the patient says"My mouth is dry" | 6 hours postoperative |
| facial flushing | My face is hot. | 6 hours postoperative |
| painkiller | the need for rescue analgesics | Up to 6 hours after study drug administration |
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |