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.

Study Overview

• Status: Active, not recruiting
• Conditions: Visual Analog Pain Scale; Inflammation Biomarkers; Quality of Recovery (QoR-15)
• Intervention / Treatment: Procedure: General Anesthesia (control group); Procedure: General Anesthesia combined with epidural anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia
      • Anesthesiology and Intensive Therapy Udayana University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group : Conventinal General Anesthesia; Patients in the control group will undergo conventional general anesthesia with a regimen of intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patient will be given opioid analgesics (Morphine dose 0.5-1 mg/hour given continuously or Fentanyl dose 10-50/hour mcg given continuously), Ketorolac 30 mg every 8 hours intravenously and Paracetamol 500 mg every 6 hours orally	Procedure: General Anesthesia (control group); 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
Experimental: Experimental Group : Conventinal General Anesthesia Combine with Epidural Anesthesia; Patients in the experimental group will undergo conventional general anesthesia combine with epidural anesthesia. The patient will undergo epidural anesthesia first with an epidural catheter, the general anesthesia with intravenous fentanyl 1-2 mcg/kg body weight, propofol 2-3 mg/kg body weight, and a muscle relaxant for intubation, such as atracurium 0.5 mg/kg body weight or rocuronium 0.6 mg/kg body weight. Afterward, the patient will undergo intubation. Before anesthesia, 2-3 mL of blood will be collected. After the operation is complete the patient will be extubated and blood samples will be taken 6 hours after surgery, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively. The patietn will be given Epidural analgesic Bupivacaine 0.1% + Morphine 0.5 mg volume 10 mL every 12 hours, Ketorolac 30 mg every 8 hours + Paracetamol 500 mg every 6 hours orally	Procedure: General Anesthesia combined with epidural anesthesia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce Interleukin 6 differences	Interleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.	before surgery and 6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce VAS pain scale	VAS scale will be collected by the anesthesiologist in charge of the patient 24 hours after surgery	24 Hours
Increase Quality of Recovery - 15	QOR-15 score will be collected by the anesthesiologist in charge of the patient 24 hours after surgery	24 Hours

Collaborators and Investigators

• Sponsor: Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2024
• Primary Completion (Estimated): January 28, 2025
• Study Completion (Estimated): January 28, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 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 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; postoperative pain; regional anesthesia; epidural anesthesia; Quality of Recovery-15; interleukin 6
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Inflammation; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 3005/UN14.2.2.VII.14/LT/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No