Combined Spinal Epidural Urinary Retention
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain, Overactive Bladder, Hospital, Urology |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | March 22, 2012 |
| End Date: | December 1, 2016 |
Do Women Receiving Low Dose Combined Spinal Epidural for Labor Analgesia Exhibit Less Bacteriuria Using a Urinary Retention Protocol Versus Routine Urinary Catheter Placement?
The investigators hypothesize that many parturients can, in fact, spontaneously micturate
with low dose combined spinal epidural analgesic doses given for labor and that Foley
catheterization is unnecessary in the majority of these parturients. At Prentice Women's
Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those
receive Foley catheters. By potentially reducing the necessity for Foley catheters, the
investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract
infections and urethritis leading to unnecessary treatment with antibiotics, as well as
reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving
low dose combined spinal epidural analgesia for analgesia after induction of labor who are
randomized to a spontaneous micturition protocol will require fewer Foley catheter placements
and demonstrate a lower incidence of positive urine culture postpartum than those who undergo
standard Foley catheter placement.
with low dose combined spinal epidural analgesic doses given for labor and that Foley
catheterization is unnecessary in the majority of these parturients. At Prentice Women's
Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those
receive Foley catheters. By potentially reducing the necessity for Foley catheters, the
investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract
infections and urethritis leading to unnecessary treatment with antibiotics, as well as
reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving
low dose combined spinal epidural analgesia for analgesia after induction of labor who are
randomized to a spontaneous micturition protocol will require fewer Foley catheter placements
and demonstrate a lower incidence of positive urine culture postpartum than those who undergo
standard Foley catheter placement.
Participation in the study will begin at the patient's request for labor analgesia. The
patient will be asked to urinate and a post void residual (PVR) will be measured via
ultrasonography. If the PVR is >100mL, the patient will be excluded from the study. If CSF is
not obtained during CSE placement or the CSE technique is abandoned for any other reason, the
patient will be excluded. If the PVR is < 100mL and the combined spinal epidural analgesia is
successful, they will be randomized to receive either routine Foley catheter placement or
begin the spontaneous micturition protocol. Last cervical exam and VRS pain will be recorded
at this time.
Subjects will be prepared in the usual fashion for the combined spinal epidural with
hemodynamic monitoring and intravenous (IV) access.
The anesthesiologist will perform a combined spinal epidural analgesia per routine with the
subject in the sitting position using sterile technique at the L3-4 interspace (± one
vertebral interspace). The epidural space will be found using loss of resistance technique
with either 3 mL of air or saline and a 17G Touhy needle. After the epidural space is
identified, the dura will be punctured with a 27G Pencan and 2.5mg of plain bupivacaine + 15
μg fentanyl will be injected. The epidural catheter will be inserted to 3-5cm into the
epidural space and a test dose of 3 mL of 1.5% lidocaine + 1:200,000 epinephrine will be
injected. The epidural catheter will be secured and the PCEA initiated with the standard
infusion rate and patient administered boluses using 0.06% bupivacaine + 2mcg/mL fentanyl.
Post-procedure vital signs will be monitored in the usual fashion.
Patients randomized to the control group will have a Foley catheter placed after the CSE is
performed as is the usual practice at this institution. Their bladder volume will be assessed
via ultrasonography before Foley catheter placement. The volume of urine collected in the
Foley bag will be used to validate our ultrasonographic measurements.
Patients randomized to the spontaneous micturition algorithm will be assessed for spontaneous
micturition and post void residual (PVR) volumes via ultrasonography at regular time
intervals. First, the patient's bladder volume is measured via ultrasonography; this is
followed by an attempt at spontaneous micturition. The patient will have an attempt at
spontaneous micturition only if their bladder contains >100mL of urine. This ensures
inability to micturate is not due to insufficient urine in the bladder prior to their
attempt. An ultrasonographic measurement of their postvoid residual volume will follow their
attempt to spontaneously micturate, to ensure the patient does not have urinary retention
necessitating Foley catheter placement.
The first attempt at spontaneous micturition is two hours after the spinal analgesic dose is
injected. A study by Campbell et al. demonstrated no urinary retention with this intrathecal
dose, but it is a possibility that the spinal dose may still be present and have a differing
effect than the epidural analgesic dose. As a result of this possibility, we decided that if
a patient has urinary retention at this first attempt, 2 hours post injection of the spinal
dose, they will have a straight catheterization and be given another chance at spontaneous
micturition more than 3 hours after the spinal dose was injected. This ensures the spinal
dose has completely worn off and the epidural analgesic dose is in effect before committing
the patient to a bed pan or Foley catheter.
Most patients will be evaluated at least twice for ability to spontaneously micturate and
have their PVR volumes accessed via ultrasonography before being assigned to either a bed pan
every 2 hours or a Foley catheter placement. If the patient is able to spontaneously
micturate twice and their PVR is <100mL, they will be assigned to a bed pan every 2 hours. If
a patient is unable to micturate with a PVR >100mL, they will receive a Foley catheter.
The spontaneous micturition algorithm allows for a maximum of 3 attempts at micturition
before a patient is committed to either a bed pan every 2 hours or Foley catheter placement.
In the event that a patient is able to spontaneously micturate but has incomplete bladder
emptying with a PVR 100-250mL, they will be allowed to continue in the algorithm for a third
and final attempt at spontaneous micturition. If the patient is able to spontaneously
micturate at this last attempt with a PVR volume <100mL, they will be assigned to a bed pan
every 2 hours but if their PVR remains >100mL they will have a Foley catheter placed.
On occasion, patients need a rescue bolus of higher concentration local anesthetic during
labor for breakthrough pain. If this occurs, the usual rebolus dose of up to 15mL of
bupivacaine 0.125% will be given in incremental doses titrated to patient comfort. Following
this rebolus, the infusion rate will be increased to 20ml/hr as is the usual practice. If a
patient who was previously assigned to use a bed pan every 2 hours requires a rescue bolus of
local anesthetic, their ability to spontaneously micturate will be reassessed 2 hours
following the rebolus to evaluate for need for reassignment to Foley catheter placement with
the higher doses of bupivacaine.
If a patient who was assigned to use a bed pan every 2 hours requires a second rebolus, they
will receive another rebolus dose of up to 15mL of bupivacaine 0.125%, the concentration of
the epidural bupivacaine infusion will be increased to bupivacaine 0.11% + fentanyl 2mcg/mL
as is our usual practice and they will automatically be assigned to a Foley catheter
placement.
If a study patient requires a cesarean delivery, a Foley catheter will be inserted at time of
decision for cesarean delivery and removed 24 hours post procedure as is the standard
practice at our institution.
The primary outcome (rate of positive urine culture) of this study will be assessed by
collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine
culture. The clinical and laboratory criteria used to define a urinary tract infection in a
woman immediately postpartum is unknown. If the patient is considered uncomplicated (normal
female urinary physiology) then she would be treated only if she has symptoms. If the patient
is considered complicated (pregnant urinary physiology) then she would be treated for
bacterial growth on urine culture even if asymptomatic. For this reason and for the purpose
of this study, if the patient is asymptomatic for urinary tract infection but has a positive
urine culture with 50,000 colony-forming units (CFU)/mL of bacteria, the patient's
obstetrician will be notified and they will likely be treated with antibiotics for suspected
urinary tract infection. This is more conservative than the current guidelines for
asymptomatic bacteriuria in pregnancy. If a positive urine culture is identified and patients
is symptomatic (at least1 sign/symptom) with the number of colonies of bacteria exceed 10,000
CFU/ml, the obstetrician will be notified and they may be treated with antibiotics for
suspected urinary tract infection. This is more conservative than the guidelines for
catheter-related infections.
In addition to the primary outcome data, the following information will be collected after
delivery: satisfaction with bladder treatment protocol (100 mm scale, 0 mm = not satisfied at
all, 100 mm = very satisfied), total labor duration, length of stage 2, mode of delivery,
presence and degree of lacerations, fetal weight, duration of Foley catheterization, time to
first spontaneous void following delivery or Foley catheter removal, total fluids
administered during labor and total dose of epidural analgesics.
In addition, a postvoid residual (PVR) will be assess via ultrasound at 8-24 hours following
delivery or foley catheter removal to assess for postpartum urinary retention. If the PVR is
found to be >100mL postpartum, this will be considered urinary retention and the obstetrician
and co-investigator (urogynecologist) will be notified.
The following demographic data will also be collected: maternal age, height, weight,
pre-pregnancy weight, and gestational age.
One telephone follow-up evaluation 8 weeks after delivery, the patient will be assessed for
treatment of urinary tract infection and urinary retention during or after discharge from the
hospital.
patient will be asked to urinate and a post void residual (PVR) will be measured via
ultrasonography. If the PVR is >100mL, the patient will be excluded from the study. If CSF is
not obtained during CSE placement or the CSE technique is abandoned for any other reason, the
patient will be excluded. If the PVR is < 100mL and the combined spinal epidural analgesia is
successful, they will be randomized to receive either routine Foley catheter placement or
begin the spontaneous micturition protocol. Last cervical exam and VRS pain will be recorded
at this time.
Subjects will be prepared in the usual fashion for the combined spinal epidural with
hemodynamic monitoring and intravenous (IV) access.
The anesthesiologist will perform a combined spinal epidural analgesia per routine with the
subject in the sitting position using sterile technique at the L3-4 interspace (± one
vertebral interspace). The epidural space will be found using loss of resistance technique
with either 3 mL of air or saline and a 17G Touhy needle. After the epidural space is
identified, the dura will be punctured with a 27G Pencan and 2.5mg of plain bupivacaine + 15
μg fentanyl will be injected. The epidural catheter will be inserted to 3-5cm into the
epidural space and a test dose of 3 mL of 1.5% lidocaine + 1:200,000 epinephrine will be
injected. The epidural catheter will be secured and the PCEA initiated with the standard
infusion rate and patient administered boluses using 0.06% bupivacaine + 2mcg/mL fentanyl.
Post-procedure vital signs will be monitored in the usual fashion.
Patients randomized to the control group will have a Foley catheter placed after the CSE is
performed as is the usual practice at this institution. Their bladder volume will be assessed
via ultrasonography before Foley catheter placement. The volume of urine collected in the
Foley bag will be used to validate our ultrasonographic measurements.
Patients randomized to the spontaneous micturition algorithm will be assessed for spontaneous
micturition and post void residual (PVR) volumes via ultrasonography at regular time
intervals. First, the patient's bladder volume is measured via ultrasonography; this is
followed by an attempt at spontaneous micturition. The patient will have an attempt at
spontaneous micturition only if their bladder contains >100mL of urine. This ensures
inability to micturate is not due to insufficient urine in the bladder prior to their
attempt. An ultrasonographic measurement of their postvoid residual volume will follow their
attempt to spontaneously micturate, to ensure the patient does not have urinary retention
necessitating Foley catheter placement.
The first attempt at spontaneous micturition is two hours after the spinal analgesic dose is
injected. A study by Campbell et al. demonstrated no urinary retention with this intrathecal
dose, but it is a possibility that the spinal dose may still be present and have a differing
effect than the epidural analgesic dose. As a result of this possibility, we decided that if
a patient has urinary retention at this first attempt, 2 hours post injection of the spinal
dose, they will have a straight catheterization and be given another chance at spontaneous
micturition more than 3 hours after the spinal dose was injected. This ensures the spinal
dose has completely worn off and the epidural analgesic dose is in effect before committing
the patient to a bed pan or Foley catheter.
Most patients will be evaluated at least twice for ability to spontaneously micturate and
have their PVR volumes accessed via ultrasonography before being assigned to either a bed pan
every 2 hours or a Foley catheter placement. If the patient is able to spontaneously
micturate twice and their PVR is <100mL, they will be assigned to a bed pan every 2 hours. If
a patient is unable to micturate with a PVR >100mL, they will receive a Foley catheter.
The spontaneous micturition algorithm allows for a maximum of 3 attempts at micturition
before a patient is committed to either a bed pan every 2 hours or Foley catheter placement.
In the event that a patient is able to spontaneously micturate but has incomplete bladder
emptying with a PVR 100-250mL, they will be allowed to continue in the algorithm for a third
and final attempt at spontaneous micturition. If the patient is able to spontaneously
micturate at this last attempt with a PVR volume <100mL, they will be assigned to a bed pan
every 2 hours but if their PVR remains >100mL they will have a Foley catheter placed.
On occasion, patients need a rescue bolus of higher concentration local anesthetic during
labor for breakthrough pain. If this occurs, the usual rebolus dose of up to 15mL of
bupivacaine 0.125% will be given in incremental doses titrated to patient comfort. Following
this rebolus, the infusion rate will be increased to 20ml/hr as is the usual practice. If a
patient who was previously assigned to use a bed pan every 2 hours requires a rescue bolus of
local anesthetic, their ability to spontaneously micturate will be reassessed 2 hours
following the rebolus to evaluate for need for reassignment to Foley catheter placement with
the higher doses of bupivacaine.
If a patient who was assigned to use a bed pan every 2 hours requires a second rebolus, they
will receive another rebolus dose of up to 15mL of bupivacaine 0.125%, the concentration of
the epidural bupivacaine infusion will be increased to bupivacaine 0.11% + fentanyl 2mcg/mL
as is our usual practice and they will automatically be assigned to a Foley catheter
placement.
If a study patient requires a cesarean delivery, a Foley catheter will be inserted at time of
decision for cesarean delivery and removed 24 hours post procedure as is the standard
practice at our institution.
The primary outcome (rate of positive urine culture) of this study will be assessed by
collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine
culture. The clinical and laboratory criteria used to define a urinary tract infection in a
woman immediately postpartum is unknown. If the patient is considered uncomplicated (normal
female urinary physiology) then she would be treated only if she has symptoms. If the patient
is considered complicated (pregnant urinary physiology) then she would be treated for
bacterial growth on urine culture even if asymptomatic. For this reason and for the purpose
of this study, if the patient is asymptomatic for urinary tract infection but has a positive
urine culture with 50,000 colony-forming units (CFU)/mL of bacteria, the patient's
obstetrician will be notified and they will likely be treated with antibiotics for suspected
urinary tract infection. This is more conservative than the current guidelines for
asymptomatic bacteriuria in pregnancy. If a positive urine culture is identified and patients
is symptomatic (at least1 sign/symptom) with the number of colonies of bacteria exceed 10,000
CFU/ml, the obstetrician will be notified and they may be treated with antibiotics for
suspected urinary tract infection. This is more conservative than the guidelines for
catheter-related infections.
In addition to the primary outcome data, the following information will be collected after
delivery: satisfaction with bladder treatment protocol (100 mm scale, 0 mm = not satisfied at
all, 100 mm = very satisfied), total labor duration, length of stage 2, mode of delivery,
presence and degree of lacerations, fetal weight, duration of Foley catheterization, time to
first spontaneous void following delivery or Foley catheter removal, total fluids
administered during labor and total dose of epidural analgesics.
In addition, a postvoid residual (PVR) will be assess via ultrasound at 8-24 hours following
delivery or foley catheter removal to assess for postpartum urinary retention. If the PVR is
found to be >100mL postpartum, this will be considered urinary retention and the obstetrician
and co-investigator (urogynecologist) will be notified.
The following demographic data will also be collected: maternal age, height, weight,
pre-pregnancy weight, and gestational age.
One telephone follow-up evaluation 8 weeks after delivery, the patient will be assessed for
treatment of urinary tract infection and urinary retention during or after discharge from the
hospital.
Inclusion Criteria:
- Nulliparous
- Term (≥37 week gestation)
- Healthy
- ASA class 1-2
- Who are being induced for labor who request labor analgesia and who successfully
receive standard combined spinal epidural analgesia (verbal rating score for pain ≤ 1
after 10 min)
Exclusion Criteria:
- Women with ASA 3 or greater
- BMI ≥40 kg/m2
- Prior history of urge or stress incontinence or urinary retention before pregnancy
- Women with a history of nephrolithiasis
- Chronic urinary tract infections
- Women whose post-void residual volume as assessed by ultrasonography is found to be
>100ml before epidural placement will be excluded.
- Women with an absolute or relative contraindication to the usual combined spinal
epidural technique
- Failed analgesia will be excluded
- Women for whom the anesthesiologist selects an analgesic technique other than combined
spinal epidural technique or fail to obtain CSF for CSE will be excluded
- Women with fetal heart rate decelerations before request for analgesia will be
excluded due to increased risk of cesarean delivery.
- Women who experience inadequate labor analgesia due to nonfunctioning epidural
catheter necessitating epidural replacement will be included but noted as a protocol
violation.
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