Epidural Analgesia and Intraoperative Fluid Management in Colorectal Surgery

NCT06810648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-02-05

No results posted yet for this study

Summary

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.

Conditions

  • ERAS
  • Colorectal Surgery
  • Goal-directed Fluid Therapy
  • Conventional Fluid Therapy
  • Epidural Analgesia

Interventions

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.

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.

PROCEDURE

CFT

Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was provided with intravenous analgesics.

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.

Sponsors & Collaborators

  • University of Ioannina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-10-23
Completion
2020-10-23

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810648 on ClinicalTrials.gov