NCT02740127 · OUTCOME

Post-operative Pain the First 24hrs

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis · Source last updated 2022-01-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Deviation
Time frame: 24 hours

What was measured

To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

Groups in this outcome

General Anesthesia and Caudal Nerve Block

If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.

General Anesthesia Only

Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
General Anesthesia and Caudal Nerve Block	24
General Anesthesia Only	28

Reported measurements

Min Pain within 24hrs

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
General Anesthesia and Caudal Nerve Block	1.1667	130.77	Not reported	Not reported	Not reported
General Anesthesia Only	0.9286	1.3859	Not reported	Not reported	Not reported

Median Pain within 24 hrs

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
General Anesthesia and Caudal Nerve Block	3.0833	2.2778	Not reported	Not reported	Not reported
General Anesthesia Only	3.7143	1.8926	Not reported	Not reported	Not reported

Max Pain within 24 hrs

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
General Anesthesia and Caudal Nerve Block	6.125	2.6096	Not reported	Not reported	Not reported
General Anesthesia Only	6.7857	2.0612	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
130.77
value
1.1667
group Id
OG001
spread
1.3859
value
0.9286
title
Min Pain within 24hrs
categories
measurements
group Id
OG000
spread
2.2778
value
3.0833
group Id
OG001
spread
1.8926
value
3.7143
title
Median Pain within 24 hrs
categories
measurements
group Id
OG000
spread
2.6096
value
6.125
group Id
OG001
spread
2.0612
value
6.7857
title
Max Pain within 24 hrs

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
28
units
Participants

description

dispersion Type

Standard Deviation

groups

description
If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
id
OG000
title
General Anesthesia and Caudal Nerve Block
description
Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
id
OG001
title
General Anesthesia Only

param Type

MEAN

reporting Status

POSTED

time Frame

24 hours

title

Post-operative Pain the First 24hrs

type

SECONDARY

unit Of Measure

score on a scale

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Preserved source evidence · Not medical advice