Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Phase: PHASE4
Conditions: Postpartum Pain, Postpartum Depression, Opioid Consumption
Sponsor: Icahn School of Medicine at Mount Sinai

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: 
A Prospective Double Blind Randomized Control Trial 
Duramorph Study Design: Prospective, Randomized Double Blinded
PI: Daniel Katz, MD
NCT04017442
Document Date: 1-11-2023

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Duramorph Study Design: Prospective, Randomized 
Double Blinded 
Unique Protocol Identification Number:  
National Clinical Trial (NCT) Identified Number: NCT04017442 
Principal Investigator: Daniel Katz 
IND/IDE Sponsor:  
Version Number: 1.000 
11 Jan 2023 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Table of Contents 
 Table of Contents - Please right-click and choose 'Update Field'. 

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STATEMENT OF COMPLIANCE 
Provide a statement that the trial will be conducted in compliance with the protocol, International 
Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal 
regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance (FWA) 
issued by the Office for Human Research Protections (OHRP) and must provide this protocol and the 
associated informed consent documents and recruitment materials for review and approval by an 
appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP. Any 
amendments to the protocol or consent materials must also be approved before implementation. Select 
one of the two statements below. If the study is an intramural NIH study, use the second statement 
below: 
1.
The trial will be carried out in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP) and the following:
o
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
OR 
2.
The trial will be conducted in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and
the [specify NIH Institute or Center (IC) [ Terms and Conditions of Award. The Principal
Investigator will assure that no deviation from, or changes to the protocol will take place
without prior agreement from the funding agency and documented approval from the
Institutional Review Board (IRB), and the Investigational New Drug (IND) or Investigational
Device Exemption (IDE) sponsor, if applicable, except where necessary to eliminate an
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study
have completed Human Subjects Protection and ICH GCP Training.
For either option above, the following paragraph would be included:
The protocol, informed consent form(s), recruitment materials, and all participant materials will
be submitted to the IRB for review and approval. Approval of both the protocol and the consent
form(s) must be obtained before any participant is consented. Any amendment to the protocol
will require review and approval by the IRB before the changes are implemented to the study.
All changes to the consent form(s) will be IRB approved; a determination will be made regarding
whether a new consent needs to be obtained from participants who provided consent, using a
previously approved consent form.

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Duramorph Study Design: Prospective, Randomized Double 
Blinded  
Study Description: 
Prospective double blind randomized control trial 
Objectives: 
Primary Objective: Analyze impact of epidural morphine on pain 
management for vaginal delivery VD 
Secondary 
Objectives: 
Analyze impact of epidural morphine on 
recovery and depression 
 
Endpoints: 
Primary Endpoint: 
Opiate consumption at 24 hours 
Secondary 
Endpoints: 
Pain score at 24 hours, obstetric revoery score 
at 24 hours, ediburgh post partum depression 
scale at 6 weeks, breast feeding success at 1 
week 
Study Population: 
Pregnant women over 18 
Phase: 
4 
Description of 
Sites/Facilities Enrolling 
Participants: 
KP2 Labor floor at Mount Sinai Hospital 
Description of Study 
Intervention: 
Epidural morphine 2mg vs placebo 
Study Duration: 
4 years 
Participant Duration: 
6 weeks 
  
 
 
1.2 SCHEMA 
1. Obtain consent 
2. 1 hour delivery administer study drug or placebo 
3. 24 hours after collect data on opiate administration, pain score, and recovery score 
4. 1 week after administration call patient inquire about breast feeding 
5. At 6 weeks after administration call patient and administer post partum depression screen 

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1.3 SCHEDULE OF ACTIVITIES (SOA) 
1. Obtain consent 
2. 1 hour delivery administer study drug or placebo 
3. 24 hours after collect data on opiate administration, pain score, and recovery score 
4. 1 week after administration call patient inquire about breast feeding 
5. At 6 weeks after administration call patient and administer post partum depression screen 
 
 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
There is no current standard of care for post vaginal delivery pain. Many different options exist, 
however, their impact on minimizing opiate utilization have been minimal. As such, we are investigating 
the utility of a single dose of preservative free morphine on pain scores in the post partum period. 
 
 
2.2 BACKGROUND 
There is no gold standard for pain management in NSVD. There is some evidence that preservative free 
morphine is effective at pain relief for cesarean deliveries. The relationship between pain and epidural 
morphine for NSVD has not been investigated. 
 
 
2.3 RISK/BENEFIT ASSESSMENT 
  
2.3.1 KNOWN POTENTIAL RISKS 
Risks can include nausea, vomiting, itching, respiratory depression 
  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Benefits include less oral and IV opiate use which also cause nausea, itching and respiratory depression. 
Benefits may also include a faster recovery and more breast feeding. The risks of this dose of morphine 
are small and have been used for cesarean delivery for decades. 
 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
  
Opiate consumption at 24 hours 
Opiate use should be 
minimized due to side 
effects 
Secondary 
  
Pain score at 24 hours 
Recovery score at 24 hours 
Breast feeding rate at 1 week 
Post partum depression screen at 6 
weeks 
Better pain control is good 
endpoint, as is recovery. 
Breastfeeding can have long 
term impacts on both mom 
and baby and it's impact 
should be investigated. 
Depression is a major issue 
post partum and controlling 
pain in the immediate post 
partum period may help 
with that. 
Tertiary/Exploratory 
  
  
  

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
Double blind, prospective, randomized control trial 
 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
When investigating the impact of a medication on pain, opiate consumption, etc, it is important for the 
study to be blinded and randomized to avoid bias. 
 
 
4.3 JUSTIFICATION FOR DOSE 
This dose is commonly administered to pregnant women for cesarean delivery. It has an excellent safety 
profile and a long history of use. 
 
 
4.4 END OF STUDY DEFINITION 
Patients complete their involvement after their 6 weeks post partum depression screen 
 
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
18 years old, pregnant, presenting for VD 
 
 
5.2 EXCLUSION CRITERIA 
Refusal of neuraxial anesthesia, allergy to morphine, patients with chronic pain syndromes or chronic 
opiate use. 
 
 
5.3 LIFESTYLE CONSIDERATIONS 
Not applicable for this study. 
 
 
5.4 SCREEN FAILURES 
Patients are consented when they have adequate pain control and are in labor. Due to patient 
convenience patients may consent to participate but not be randomized based on their time of delivery. 
These patients will be kept in a separate log. 
 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
We will use the clinical anesthesia team to inform us of potential patients. They have been educated 
about the study.  
 
 

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6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
Epidural morphine 2mg  
6.1.2 DOSING AND ADMINISTRATION 
  
2 mg (4ml) will be administered one hour after the patient has their VD. It will be administered through 
their in situ epidural 
 
 
6.2 PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
  
6.2.1 ACQUISITION AND ACCOUNTABILITY 
Investigational Drug Service stocks the Pyxis machine with the study drug. it uses real time automated 
biometric safety protocols to ensure only those able to administer the study drug are allowed to remove 
it 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
PI attached to IRB application. it is a brown ampule with 10mg total in the vial. 
6.2.3 PRODUCT STORAGE AND STABILITY 
It is stored in the Pyxis machine as per requirements 
6.2.4 PREPARATION 
After removal from the Pyxis machine the study drug is steriley drawn up into a syringe and labeled 
"study drug". This is then handed off to a different member of the study team to administer. The 
remainder is returned to the drug lockbox as per protocol 
 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
All patients presenting for VD are eligible and the clinical teams are trained in implicit bias and have had 
special education from the research team for this study. Given the randomization we cannot demand 

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that any specific group be targeted for recruitment. We want an equitable and balanced sample for our 
study. 
 
 
6.4 STUDY INTERVENTION COMPLIANCE 
Each step is recorded in either the datasheets or Pyxis logs. After the administration all that remains is 
data collection from the patients. Given that we contact patients at the required times we expect a high 
level of compliance. 
 
 
6.5 CONCOMITANT THERAPY 
  
6.5.1 RESCUE MEDICINE 
Any patients on opiates or with an allergy to morphine are excluded and as such there is no risk for 
synergistic effects of the study drug. As per our CD protocol, we provide the same rescue doses of 
medications for morphine including ondanstetron, diphenhydramine, and nalxone all as needed. 
 
 

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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
Should we experience any cases of respiratory depression we will stop the study and review the case.  
 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants may withdraw from the study at any time by notifying the study team and/or the PI either 
verbally or in written form. 
 
 
7.3 LOST TO FOLLOW-UP 
Given that one of our endpoints is 6 weeks out we expect to loose some patients to follow up. This will 
impact our findings, however, our study is powered for our primary endpoint which is opiate 
consumption at 24 hours. We expect little or no followup loss for this endpoint. 
 
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 EFFICACY ASSESSMENTS 
At 24 hours we will get a likert pain score, as well as a recovery score. We will also obtain opiate 
consumption for this time. 
  
 
 
8.2 SAFETY AND OTHER ASSESSMENTS 
At one week we will ask patients about breast feeding. At 6 weeks we will ask about depression 
 
 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse events include nausea and itching 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
Serious adverse event would be respiratory depression requiring naloxone administration 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
Classification of an adverse event is based on symptomatology type as described above. 
8.3.3.1 SEVERITY OF EVENT 
As above, severity is determined by need to administer rescue medications and type. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
We will examine each case and determine relationship to the study intervention. 
8.3.3.3 EXPECTEDNESS 
We expect to have cases of nausea and itching, we anticipate no cases of respiratory depression 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Patients are monitored according to post partum protocols. The areas the patients recover are all 
equipped to manage patients after receiving neuraxial morphine. 

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8.3.5 ADVERSE EVENT REPORTING 
We receive reports from patients about their AEs on follow up or from the clinical team if they bring it 
up. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
All patients are monitored for respiratory depression. All cases of this are reported to our internal PI 
committee and reviewed independently.  
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
All AEs are reported to participants. 
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY 
N/A 
 
 
8.4 UNANTICIPATED PROBLEMS 
  
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
There are no unanticipated problems with this study, however, should any issue occur the PI will be 
available to discuss 
8.4.2 UNANTICIPATED PROBLEM REPORTING 
At any time any participant, clinical team member, or study team member can report and event to the 
PI. 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
Those that may impact patient care and well being will be reported to all participants. 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
 
Primary Efficacy Endpoint(s): 
Opiate consumption at 24 hours (Wilcoxon Rank Sum) 
 
Secondary Efficacy Endpoint(s): 
Recovery score at 24 Hours (Wilcoxon Rank Sum) 
Breast feeding at 1 week (Chi Square) 
Depression screen at 6 weeks (Wilcoxon Rank Sum) 
 
 
9.2 SAMPLE SIZE DETERMINATION 
Based on other works it was determined that for a 25% reduction in opiate utilization we needed 60 
patients for each group. To account for drop off we will recruit 150 patients per group for a total of 300 
patients 
 
 
9.3 POPULATIONS FOR ANALYSES 
This will be intention to treat for all randomized participants. 
 
 
9.4 STATISTICAL ANALYSES 
  
9.4.1 GENERAL APPROACH 
Wilcoxon rank sum for continous variables, chi square for categorical 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
Wilcoxon rank sum 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Recovery score and depression score: Wilcoxon Rank Sum, Breast feeding: Chi square 

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9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Given randomization we will simply report, not anlayze 
9.4.6 PLANNED INTERIM ANALYSES 
N/A 
9.4.7 SUB-GROUP ANALYSES 
N/A 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Will be performed using secured encrypted software (RedCap) and SPSS software 
9.4.9 EXPLORATORY ANALYSES 
Not applicable 
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
  
10.1.1 INFORMED CONSENT PROCESS 
After the patient is comfortable from their epidural the clinical team will get assent for the research 
team to approach the patient. The research team will then consent the patient using standardized 
process in compliance with IRB protocols 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
N/A 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
As per IRB standard protocol 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
Upon notification of withdrawal participants can either elect to have their data destroyed, or allow the 
research team to analyze data obtained. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
All data is gathered via a study ID with a linking code. ONLY the PI has access to the code which is stored 
in a locked office on a locked computer that is password protected and encrypted. As such the 
information is de-identified. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
N/A 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Medical Monitor 
Daniel Katz 
  
daniel.katz@mountsinai.org 
  
732-322-6675 
  
1 Gustave L Levy Place Box 1010 
  
KCC 8th Floor NY, NY 10029 
  
  
10.1.6 SAFETY OVERSIGHT 
The PI will examine all cases of AE and SAE  

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10.1.7 CLINICAL MONITORING 
All patients are monitored as per hospital protocols. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
The PI will handle all study related issues in regards to QA and QI Except for respiratory depression 
events. These will be investigated by the departmental QI committee. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
All data are collected on de-identified forms. These are then put into a de-identified Redcap secured 
database. The PI will review records on an ad hoc basis for completeness and accuracy.  
  
  
10.1.9.2 STUDY RECORDS RETENTION 
Will be kept for 5 years after completion and then destroyed 
10.1.10 PROTOCOL DEVIATIONS 
  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
We will not be sharing individual results with patients, however, we will publish our results in a medical 
journal. 
  
10.1.12 CONFLICT OF INTEREST POLICY 
As per the FCOI office of our institution 
 
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
 
 
10.3 ABBREVIATIONS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 

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CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 

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SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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11 REFERENCES