Epidural Analgesia and Intraoperative Fluid Management in Colorectal Surgery

NCT06810648 | Completed

• 1 other identifier: 06-15/09/2016
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Total fluids

  From beginning of surgery until PACU (post anaesthesia care unit) discharge, an average of 5 hours.

• proBNP levels

  From 20-24 hours before surgery to 20-24 hours after surgery.

• All-cause in hospital mortality

  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

  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

  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.

Study Arms (4)

GDFT group

EXPERIMENTAL

Patients in the GDFT group were managed perioperatively using goal-directed fluid administration and continuous intravenous analgesia.

Procedure: GDFT

GDFT/ED group

EXPERIMENTAL

Patients in the GDFT/ED group were managed perioperatively using goal-directed fluid administration and epidural analgesia.

Procedure: GDFT/ED

CFT

EXPERIMENTAL

Patients in the CFT group were managed perioperatively using conventional fluid administration and continuous intravenous analgesia.

Procedure: CFT

CFT/ED

EXPERIMENTAL

Patients in the CFT group were managed perioperatively using conventional fluid administration and epidural analgesia.

Procedure: CFT/ED

Interventions

GDFT PROCEDURE

Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was provided with intravenous analgesics.

Also known as: Prospective group

GDFT group

GDFT/ED PROCEDURE

Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was administered via epidural analgesics.

Also known as: Prospective group

GDFT/ED group

CFT PROCEDURE

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

Also known as: Retrospective group

CFT

CFT/ED PROCEDURE

Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was administered via epidural analgesics.

Also known as: Retrospective group

CFT/ED

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (2)

"Attikon" Hospital

Athens, Attica, 12462, Greece

Location

University Hospital of Ioannina

Ioannina, Epirus, 455 00, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Model Details: Patients were randomly allocated into four groups based on different anesthetic modalities for intraoperative fluid management and analgesic strategy: The GDFT group received goal-directed fluid therapy and continuous intravenous analgesia, the GDFT/ED group received goal-directed fluid therapy and epidural analgesia, the CFT group received conventional fluid administration and continuous intravenous analgesia, and the CFT/ED group received conventional fluid administration and epidural analgesia. Data for the GDFT and GDFT/ED groups were collected prospectively, while data for the CFT and CFT/ED groups were collected retrospectively

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 5, 2025
• Study Start: May 1, 2017
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

GR (2)