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NCT Number: NCT06784258

Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital

Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery.

Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Inflammation Biomarkers Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Recovery (QoR-15) Rectal Diseases Signs and Symptoms Visual Analog Pain Scale

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia

About this study

Patients will be divided into 2 groups: Group P (treatment) and Group K (control).

Before anesthesia, 2-3 mL of blood will be collected by the researcher from patients in both groups using a red tube.

Patients in the control group will undergo conventional general anesthesia. Patients in the treatment group will undergo conventional general anesthesia combined with epidural anesthesia. Patients will be administered 0.25% Bupivacaine local anesthetic incrementally until the desired volume is achieved based on the targeted segmental block height.

Six hours postoperatively, 2-3 mL of blood will be collected, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 - 65 years
  • Patients with ASA physical status I - III

Exclusion criteria

  • Patients with contraindications to regional anesthesia
  • Patients with mental disorders or psychiatric disorders
  • The patient has a history of allergy to the local anesthetic used.
  • The patient or family refuses to take part in the study
  • BMI > 30 Kg/m2

Treatment and study plan

General Anesthesia (control group)

Procedure

The patient will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/kg BB. After that the patient will be intubated

General Anesthesia combined with epidural anesthesia

Procedure

The patient will undergo epidural anesthesia first with an epidural catheter inserted through a Tuohy needle and ensuring that the length of the multihole epidural catheter that enters the epidural space is 5-6 cm. After that, the patient underwent conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg BW, propofol 2-3 ml/kg BW, and muscle relaxants for intubation, such as atracurium 0.5 mg/kg BW or rocuronium 0.6 mg/ kg BW. After that the patient will be intubated. The patient will be given local anesthesia Bupivacaine 0.25% in increments to the desired volume according to the desired height of the segmental block. Local anesthetic medication will be given intermittently every 2 hours

Primary outcomes

  1. Reduce Interleukin 6 differences

    Time frame: before surgery and 6 hours after surgery

    Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.

Secondary outcomes

  1. Reduce VAS pain scale

    Time frame: 24 Hours

    VAS scale will be collected by the anesthesiologist in charge of the patient 24 hours after surgery

  2. Increase Quality of Recovery - 15

    Time frame: 24 Hours

    QOR-15 score will be collected by the anesthesiologist in charge of the patient 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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