Epidural Analgesia and Intraoperative Fluid Management in Colorectal Surgery

Effect of Epidural Analgesia on Goal-Directed Fluid Therapy Using Stroke Volume Variation in Elective Major Abdominal Surgery Involving Low Risk Patients: A Cohort Study

The Enhanced Recovery After Surgery (ERAS) protocols have demonstrated their efficacy in expediting recovery and minimizing postoperative complications, especially in patients undergoing abdominal surgery. Perioperative hydration is one of the most critical pillars of the ERAS protocols, with goal-directed methods for administering fluids increasingly incorporated into these protocols.

The Goal-Directed Fluid Therapy (GDFT) method is a strategy used in perioperative and critical care settings to optimize fluid administration tailored to a patient's individual needs. Its goal is to maintain adequate tissue perfusion and oxygenation by precisely balancing fluid administration, avoiding both hypovolemia (too little fluid) and fluid overload. Rather than using a "one-size-fits-all" approach, GDFT adjusts fluid delivery based on real-time monitoring of the patient's physiological parameters. GDFT focuses on dynamic hemodynamic indicators, such as stroke volume (SV), stroke volume variation (SVV), and cardiac output (CO), which provide better insight into the patient's fluid responsiveness. Advanced monitoring tools, such as esophageal Doppler, pulse contour analysis, or invasive devices like a pulmonary artery catheter, are used to assess the patient's response to fluid administration. The implementation of such protocols, particularly in colorectal surgery, has proven beneficial, as both overhydration and underhydration in this context can significantly impair organ function and, consequently, affect patient outcomes. Hypovolemia may lead to tissue ischemia at the anastomotic site, potentially causing breakdown. Conversely, fluid overload can have harmful consequences; hyperhydration may cause tissue edema, thereby reducing anastomotic strength. However, these findings have been validated primarily in high-risk patients, with a limited number of studies involving low- to moderate-risk patients undergoing major abdominal surgery.

Colorectal surgery is routinely managed with epidural analgesia combined with general anaesthesia. However, concerns have been raised that epidurally induced sympathetic blockade and vasoplegia (vasodilation) can cause haemodynamic instability, necessitating fluid and vasopressor administration to an uncertain extent.

In this single-center trial, we aimed to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV)-guided GDFT using the FloTrac/Vigileo monitor during major open abdominal surgery. The study hypothesis was that epidural analgesia may result in fluid overload to compensate for the induced vasoplegia and that this fluid overload, in turn, could lead to gastrointestinal dysfunction and prolong the length of hospital stay.

The primary outcomes were the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay following elective colorectal surgery in patients managed with GDFT, either with or without epidural analgesia. Additionally, patient records of those treated with conventional fluid therapy (CFT), with or without epidural analgesia, were reviewed retrospectively for comparison.

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Colorectal Surgery; ERAS; Goal-directed Fluid Therapy; Conventional Fluid Therapy
• Intervention / Treatment: Procedure: GDFT; Procedure: GDFT/ED; Procedure: CFT; Procedure: CFT/ED

Detailed Description

Existing evidence regarding the implementation of Enhanced Recovery After Surgery (ERAS) protocols highlights their benefits in accelerating the recovery process and reducing hospital stay durations. Additionally, postoperative morbidity, mortality, and rehospitalization rates are lower in patients following these protocols. A key component of ERAS protocols is perioperative fluid management, which is critical for gastrointestinal recovery after major abdominal surgery. Both overhydration and underhydration can significantly impair organ function and, consequently, affect patient outcomes.

Goal-directed fluid therapy (GDFT), utilizing dynamic volume measurements, enables balanced fluid administration. Numerous studies support the implementation of such protocols, particularly in major abdominal surgeries. Colonic anastomotic leakage is one of the most serious complications following colorectal surgery, with a reported incidence of up to 20%. Anastomotic breakdown is associated with increased morbidity and mortality, resulting in prolonged hospitalization, depletion of healthcare resources, and elevated costs. Hypovolemia can lead to tissue ischemia at the anastomotic site, causing breakdown. Conversely, fluid overload may have harmful consequences; hyperhydration can lead to tissue edema, thereby reducing anastomotic strength. These findings underscore the importance of maintaining euvolemia during colorectal surgeries, supporting the inclusion of GDFT as an essential component of the anesthetic protocol. However, the benefits of GDFT in abdominal surgery have been predominantly investigated and validated in high-risk patients. Only a limited number of studies involve low- to moderate-risk patients undergoing major abdominal surgery.

Epidural analgesia, combined with general anaesthesia, is considered the gold standard anaesthetic regimen for major abdominal surgery. However, the resulting sympathetic blockade and vasoplegia can cause haemodynamic instability, affecting fluid administration and vasopressor requirements to an uncertain extent. Various clinical and laboratory markers have been employed to monitor the effects of perioperative fluid management. Evidence suggests that B-type Natriuretic Peptide (BNP) levels are associated with fluid balance, morbidity and mortality at 30 days or even 180 days after non-cardiac surgery, and length of hospital stay. However, the concept of using risk predictors such as BNP in surgeries involving significant fluid loss and redistribution, such as colorectal surgeries, remains insufficiently studied.

This single-center trial was conducted to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV) guided GDFT using the FloTrac/Vigileo monitor in major open abdominal surgery. The study hypothesis was that epidural analgesia may result in overhydration to compensate for the induced vasoplegia, thereby affecting gastrointestinal function and length of hospital stay. The primary outcome was the effect of epidural analgesia on the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay in low- to moderate-risk patients undergoing open major abdominal surgery managed with intraoperative GDFT. Secondary outcomes included the total volume of fluids administered, assessment of proBNP levels as a marker of fluid balance, incidence of postoperative adverse events, and all-cause in-hospital mortality. Additionally, patients' records treated with conventional fluid therapy (CFT) with or without epidural analgesia were reviewed retrospectively for comparison.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • "Attikon" Hospital
  • Epirus
    • Ioannina, Epirus, Greece, 455 00
      • University Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults
• elective oncological colorectal surgery
• ASA (American Society of Anesthesiologists physical status classification) I & II

Exclusion Criteria:

• extremes of weight (< 55 kg or > 120 kg)
• known history of arrhythmias
• recent unstable coronary syndrome
• decompensated heart failure
• severe aortic valve stenosis
• impaired renal function (serum creatinine level > 2.0 mg/dL)
• inability to communicate
• refusal to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDFT group; Patients in the GDFT group were managed perioperatively using goal-directed fluid administration and continuous intravenous analgesia.	Procedure: GDFT; Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was provided with intravenous analgesics.; Other Names: Prospective group
Experimental: GDFT/ED group; Patients in the GDFT/ED group were managed perioperatively using goal-directed fluid administration and epidural analgesia.	Procedure: GDFT/ED; Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was administered via epidural analgesics.; Other Names: Prospective group
Experimental: CFT; Patients in the CFT group were managed perioperatively using conventional fluid administration and continuous intravenous analgesia.	Procedure: CFT; Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was provided with intravenous analgesics.; Other Names: Retrospective group
Experimental: CFT/ED; Patients in the CFT group were managed perioperatively using conventional fluid administration and epidural analgesia.	Procedure: CFT/ED; Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was administered via epidural analgesics.; Other Names: Retrospective group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal dysfunction	Postoperative ileus, anastomotic leak, anastomotic breakdown, gastrointestinal bleeding.	From day of surgery untill 30 days after surgery.
Length of hospital stay	Duration (days) from admission to hospital discharge	From day of admission to day of discharge, an average of 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fluids	Total volume of fluids administered intraoperatively.	From beginning of surgery until PACU (post anaesthesia care unit) discharge, an average of 5 hours.
proBNP levels	Measurement of proBNP (pro B-type natriuretic peptide) blood levels at two time points: pre- and postoperatively.	From 20-24 hours before surgery to 20-24 hours after surgery.
All-cause in hospital mortality	Total number of deaths that occur within a hospital setting, regardless of the underlying cause.	From day of admission to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Postoperative pulmonary complications	Respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, acute respiratory distress syndrome [ARDS], pulmonary edema, exacerbation of pre-existing lung disease, and pulmonary embolism.	From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Major adverse cardiovascular events	Stroke, myocardial infarction, cardiovascular death	From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Acute kidney injury	Postoperative injury to the kidneys is reflected by at least a twofold increase in baseline serum creatinine.	From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Reoperation	Need for reoperation and return to the theater after PACU (post anaesthesia care unit) discharge.	From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
ICU admission	Unplanned ICU (intensive care medicine) admission after surgery.	From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 06-15/09/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No