Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Inflammation Biomarkers
Quality of Recovery (QoR-15)
Visual Analog Pain Scale
Keywords: epidural anesthesia
interleukin 6
postoperative pain
colorectal cancer
regional anesthesia
Quality of Recovery-15
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Colorectal patient undergoing elective surgery
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduce Interleukin 6 differences
timeFrame: before surgery and 6 hours after surgery
Secondary outcomes:
measure: Reduce VAS pain scale
timeFrame: 24 Hours
measure: Increase Quality of Recovery - 15
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Anesthesiology and Intensive Therapy Udayana University
state: Bali
Study officials:
References: