Effect of OFA in Laparoscopic Gastrectomy

Postoperative Pain Clinical Trial

Official title:

Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076903
• Other study ID #: 3-2021-0295
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: January 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• OFA
Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 µg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 µg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.
• Control
Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Gangnam Severance Hsopital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Anxiety Depression Scale	Score of HADS questionnaire (Hospital Anxiety Depression Scale). It consists of 14 items and each item is scored on a scale of 0-3.	1-5 days before surgery
Other	Euro Quality of Life - 5 Dimensions	Score of EQ-5D-5L questionnaire (Five-level version of Euro Quality of Life - 5 Dimensions). It consists of 5 items, and each item is scored on a scale of 1-5.	1-5 days before surgery
Other	Patient Health Questionnaire	Score of PHQ-15 questionnaire (Patient Health Questionnaire-15). It consists of 15 items, and each item is scored on a scale of 0-2.	1-5 days before surgery
Other	Pain Catastrophizing Scale	Score of PCS questionnaire (Pain Catastrophizing Scale). It consists of 13 items, and each item is scored on a scale of 0-4.	1-5 days before surgery
Other	Big Five Inventory-10	Score of BFI-10 questionnaire (Big Five Inventory-10). It consists of 10 items, and each item is scored on a scale of 1-5.	1-5 days before surgery
Other	Hamilton Depression Rating Scale	Score of HAM-D (Hamilton Depression Rating Scale) examination. It consists of 17 items to evalulate depression, and higher scores indicate more severe depression.	1-5 days before surgery
Other	Hamilton Anxiety Rating Scale	Score of HAM-A (Hamilton Anxiety Rating Scale) examination. It consists of 14 items to evalulate anxiety, and higher scores indicate more severe anxiety.	1-5 days before surgery
Other	PainDETECT	Score of PainDETECT questionnaire. It consists of items such as the quality of pain, the pattern of pain, and higher scores indicate more severe neuropathic pain.	1-5 days before surgery
Other	Temporal pain summation	Compare the pain after a single stimulation with the pain after 10 repeated stimulations.	1-5 days before surgery
Other	Pressure pain threshold	The lowest pressure at which the participant perceives pain. It is measured by pressure algometry.	1-5 days before surgery
Other	Pressure pain tolerance	The highest pressure when the participant perceived untolerable pain. It is measured by pressure algometry.	1-5 days before surgery
Other	Frontal Electroencephalogram	Band power and connectivity in electroencephalogram	perioperative period
Other	Analgesia Nociception Index (ANI)	Analgesia Nociception Index (ANI) from ANI monitoring	perioperative period
Primary	Opioid consumption in postoperative 24hrs	Total opioid dose administered to the patient.	24 hours after surgery
Secondary	Opioid consumption	Total opioid dose administered to the patient.	postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
Secondary	Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)	Time (hours) to first gas passing / starting oral fluid intake / starting soft diet	up to 2weeks
Secondary	Pain score	verbal numerical rating scale 0-10	postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
Secondary	Nausea score	verbal numerical rating scale 0-10	postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Secondary	Time to rescue analgesics after surgery	Time (hours) to first rescue analgesics	up to 2weeks
Secondary	Number of vomiting, antiemetic adeministration	Number of vomiting, antiemetic adeministration	up to 2weeks
Secondary	Hemodynamics during surgery	changes in hemodyanamics during surgery	during surgery
Secondary	QoR-15	Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)	1-5 days before surgery, postoperative 1day, postoperative 4day
Secondary	PCL-5	Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)	postoperative 1week