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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06784258
Enrollment
44
Registered
2025-01-20
Start date
2024-12-28
Completion date
2025-01-28
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

PROCEDUREGeneral 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

Sponsors

Udayana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Colorectal patient undergoing elective surgery

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduce Interleukin 6 differencesbefore surgery and 6 hours after surgeryInterleukin 6 will be collected before surgery and 6 hours after surgery by the anesthesiologist in the Operating theatre.

Secondary

MeasureTime frameDescription
Reduce VAS pain scale24 HoursVAS scale will be collected by the anesthesiologist in charge of the patient 24 hours after surgery
Increase Quality of Recovery - 1524 HoursQOR-15 score will be collected by the anesthesiologist in charge of the patient 24 hours after surgery

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026