The Prevention of Hypotension After Epidural Analgesia After Major Surgery

NCT02722746 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB201600185
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely and very successfully used routinely for perioperative pain control in patients undergoing major orthopedic and abdominal surgery since 1928. The choice currently depends on the preference of the APS physician in charge of the case. A frequent unwanted side effect of epidural block is hypotension due to the epidurally injected LA blocking the sympathetic nerves and thus the patient's response to hypotension, which is usually due to hypovolemia and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this research study is to see if adding epinephrine, to the epidural anesthetic will decrease possible side effects, such as low blood pressure, and lead to a better effect of the epidural anesthetic.

Conditions

Hypotension; Pain

Keywords

Epidural Analgesia

Outcome Measures

Primary Outcomes (1)

• Changes Between the 3 Groups Assessed by Blood Pressure Measurement

  Hypotension will be assessed by systolic blood pressure (SBP) \> 20% below the baseline preoperative measurements and acquired before the epidural or any sedation has been administered and the intra-operative period. The median time to end of intraoperative period was 2:37 (hours:min), ranging from 0:53 to 7:30.

  Change from baseline to end of the intra-operative period

Secondary Outcomes (12)

• Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect

  Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU)

• Changes Between the 3 Groups Assessed by Ambulation After Surgery

  From post-operative (post-op) day 1 to post-op day 3

• Changes Between the 3 Groups Assessed by Opioid Usage

  From day of surgery (0) to post-op day 3

• Changes Between the 3 Groups Assessed by Opioid-related Side Effects

  From day of surgery (0) to post-op day 3

• Changes Between the 3 Groups Assessed by Fluid Balance

  From post-op day 1 to post-op day 3

Study Arms (3)

Ropivacaine only Control group

PLACEBO COMPARATOR

The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure.

Drug: Ropivacaine

Ropivacaine + 2 mcg/mL epinephrine

ACTIVE COMPARATOR

The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure.

Drug: Ropivacaine; Drug: Epinephrine

Ropivacaine + 5 mcg/mL epinephrine

ACTIVE COMPARATOR

The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure.

Drug: Ropivacaine; Drug: Epinephrine

Interventions

Ropivacaine DRUG

Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.

Also known as: Naropin

Ropivacaine + 2 mcg/mL epinephrine; Ropivacaine + 5 mcg/mL epinephrine; Ropivacaine only Control group

Epinephrine DRUG

Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment.

Also known as: Adrenalin

Ropivacaine + 2 mcg/mL epinephrine; Ropivacaine + 5 mcg/mL epinephrine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing epidural analgesia to treat perioperative pain associated with major surgery
• undergoing major thoracic surgery
• undergoing major abdominal surgery
• undergoing major orthopaedic surgery

You may not qualify if:

• sepsis
• acute trauma
• coagulopathy
• preoperative hemodynamic instability
• symptomatic coronary artery disease
• patients from the ICU whose tracheas were intubated for any cause
• allergies to medications in the protocol
• primary or secondary block failure

Sponsors & Collaborators

• University of Florida: lead
• I. Heermann Anesthesia Foundation: collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Nin OC, Boezaart A, Giordano C, Hughes SJ, Parvataneni HK, Reina MA, Schirmer A, Vasilopoulos T. Pilot epinephrine dose-finding study to counter epidural-related blood pressure reduction. Reg Anesth Pain Med. 2025 Nov 5;50(11):901-906. doi: 10.1136/rapm-2024-105406.

  PMID: 38991714 DERIVED

MeSH Terms

Conditions

Hypotension; Pain

Interventions

Ropivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Terrie Vasilopoulos
• Organization: University of Florida, College of Medicine

tvasilopoulos@anest.ufl.edu

3522738910

Study Officials

• Olga C. Nin, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 30, 2016
• Study Start: November 15, 2016
• Primary Completion: October 4, 2017
• Study Completion: September 14, 2018
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)