Postoperative PainNCT05076903
Effect of OFA in Laparoscopic Gastrectomy
A study testing OFA in people with Postoperative Pain, run by Gangnam Severance Hospital at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- OFA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 14 Sep 2021to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer
Who cannot join
- 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
Show all 14Show fewer
- 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.)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Gangnam Severance Hospital
Seoul
Gangnam Severance Hsopital
Seoul
About this study
Official title: Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
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.
- Conditions
- Postoperative Pain
- Being tested
- OFA, Control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFADrug
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.
ControlDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| OFA group | Experimental | 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. Receives: Drug: OFA |
| Control group | Active comparator | 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. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in postoperative 24hrs
Total opioid dose administered to the patient.
Measured: 24 hours after surgery
Secondary outcomes (9)
Opioid consumption
Total opioid dose administered to the patient.
Measured: postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
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
Measured: up to 2weeks
Pain score
verbal numerical rating scale 0-10
Measured: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
Nausea score
verbal numerical rating scale 0-10
Measured: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Time to rescue analgesics after surgery
Time (hours) to first rescue analgesics
Measured: up to 2weeks
Number of vomiting, antiemetic adeministration
Number of vomiting, antiemetic adeministration
Measured: up to 2weeks
Hemodynamics during surgery
changes in hemodyanamics during surgery
Measured: during surgery
QoR-15
Score of QoR-15 questionnaire (Quality of Recovery-15)(Minimum value: 0, Maximum value: 150, higher scores means better.)
Measured: 1-5 days before surgery, postoperative 1day, postoperative 4day
PCL-5
Score of PCL-5 (Posttraumatic stress disorder Checklist for DSM-5) (Minimum value: 0, Maximum value: 80, higher scores means worse.)
Measured: postoperative 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start14 Sep 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076903
- Sponsor's protocol ID
- 3-2021-0295
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bae MI, Oh J, Lee HS, Park S, Kwon IG, Song Y. Influence of psychological factors and pain sensitivity on the efficacy of opioid-free anesthesia: A randomized clinical trial. Gen Hosp Psychiatry. 2024 Jul-Aug;89:84-92. doi: 10.1016/j.genhosppsych.2024.04.001. Epub 2024 Apr 4.
PubMed 38838608
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
- ClinicalTrials.gov ID
- NCT05076903
- Acronym / sponsor ID
- 3-2021-0295
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFA group | Experimental | Drug: OFADexmedetomidine 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 group | Active comparator | Drug: ControlRemifentanil 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFADexmedetomidine 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. | Drug | OFA group |
| ControlRemifentanil 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. | Drug | Control group |
Primary outcome
Opioid consumption in postoperative 24hrs
Time frame: 24 hours after surgery
Total opioid dose administered to the patient.
9 secondary outcomes
Opioid consumption
Time frame: postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days
Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)
Time frame: up to 2weeks
Pain score
Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks
Nausea score
Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Time to rescue analgesics after surgery
Time frame: up to 2weeks
Number of vomiting, antiemetic adeministration
Time frame: up to 2weeks
Hemodynamics during surgery
Time frame: during surgery
QoR-15
Time frame: 1-5 days before surgery, postoperative 1day, postoperative 4day
PCL-5
Time frame: postoperative 1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 38838608Bae MI, Oh J, Lee HS, Park S, Kwon IG, Song Y. Influence of psychological factors and pain sensitivity on the efficacy of opioid-free anesthesia: A randomized clinical trial. Gen Hosp Psychiatry. 2024 Jul-Aug;89:84-92. doi: 10.1016/j.genhosppsych.2024.04.001. Epub 2024 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFA in people with Postoperative Pain, run by Gangnam Severance Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption in postoperative 24hrs (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.