Clinical trial NCT05076903: Effect of OFA in Laparoscopic Gastrectomy
Official title: Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.

And investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.


Eligibility criteria: Inclusion Criteria:

* Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer

Exclusion Criteria:

* Patients with a history of allergic reactions to drugs
* Patients with a history of drug addiction
* Patients with chronic pain who require analgesics
* Patients with cancer other than the stomach
* History of hospitalization for psychiatric disorders
* Patients with sleep apnea
* Preoperative pulse oximetry (SpO2) \< 95 %
* Moderate or severe hepatic impairment
* bradycardia (HR\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block
* Body mass index over 35 kg/m2
* Blood clotting disorders
* Pregnant/lactating women
* Cognitive impairment
* Unable to read consent form (eg illiterate, foreigner, etc.)

Primary outcomes:
measure: Opioid consumption in postoperative 24hrs
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
measure: Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)
timeFrame: up to 2weeks
measure: Pain score
timeFrame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
measure: Nausea score
timeFrame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
measure: Time to rescue analgesics after surgery
timeFrame: up to 2weeks
measure: Number of vomiting, antiemetic adeministration
timeFrame: up to 2weeks
measure: Hemodynamics during surgery
timeFrame: during surgery
measure: QoR-15
timeFrame: 1-5 days before surgery, postoperative 1day, postoperative 4day
measure: PCL-5
timeFrame: postoperative 1week
Other outcomes:
measure: Hospital Anxiety Depression Scale
timeFrame: 1-5 days before surgery
measure: Euro Quality of Life - 5 Dimensions
timeFrame: 1-5 days before surgery
measure: Patient Health Questionnaire
timeFrame: 1-5 days before surgery
measure: Pain Catastrophizing Scale
timeFrame: 1-5 days before surgery
measure: Big Five Inventory-10
timeFrame: 1-5 days before surgery
measure: Hamilton Depression Rating Scale
timeFrame: 1-5 days before surgery
measure: Hamilton Anxiety Rating Scale
timeFrame: 1-5 days before surgery
measure: PainDETECT
timeFrame: 1-5 days before surgery
measure: Temporal pain summation
timeFrame: 1-5 days before surgery
measure: Pressure pain threshold
timeFrame: 1-5 days before surgery
measure: Pressure pain tolerance
timeFrame: 1-5 days before surgery
measure: Frontal Electroencephalogram
timeFrame: perioperative period
measure: Analgesia Nociception Index (ANI)
timeFrame: perioperative period
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hsopital
Study officials:
References: