Postoperative HyperalgesiaNCT05016128
Intraoperative S-ketamine to Prevent Postoperative Hyperalgesia in Patients Undergoing Video-assisted Thoracic Surgery
A study testing S-ketamine and saline in people with Postoperative Hyperalgesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Hyperalgesia
- What is being tested?
- S-ketamine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2021to 30 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status class I-III.
- elective single-port video-assisted thoracic surgery under general
Who cannot join
- a history of thoracic surgery
- a history of chronic pain
- ongoing pain treatment
- opioid drug or alcohol abuse
- a history of allergy to anesthetics
- obesity (body mass index [BMI] >30 kg/m2 )
Show all 12Show fewer
- pregnancy
- psychiatric disorders
- neurological disease
- severe diabetes
- renal or hepatic insufficiency
- uncontrolled hypertension, or arrhythmia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second affiliated Hospital School of Medicine,Zhejiang University
Hangzhou, Zhejiang
lina Yu, doctor
About this study
Official title: Second Affiliated Hospital Zhejiang University School of Medicine
Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Opioid-induced hyperalgesia (OIH) and nociceptive-induced hyperalgesia (NIH) are the two main causes of POH.N-methyl-D-aspartate receptor (NMDAR) activation plays a central role in the development of POH.S-ketamine，which is a NMDA-receptor antagonist,has been on the market in china since 2019.The aim of this study is to evaluate the effects of S-ketamine on POH and chronic postoperative pain after video-assisted thoracic surgery.
- Conditions
- Postoperative Hyperalgesia
- Being tested
- S-ketamine, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
Also called esketamine
S-ketamine is used for preventing postoperative hyperalgesia,thus reducing the patient's acute postoperative pain
salineDrug
Also called 0.9%saline
saline is used for control
| Study group | Role | What they receive |
|---|---|---|
| S-ketamine | Experimental | a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery Receives: Drug: S-ketamine |
| Saline | Placebo comparator | a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mechanical pain threshold around the incision
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 ) hand-held Von Frey filaments (North Coast Medical Inc.USA)around the skin incision.The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 6 measurements at 2 cm vertically above and below the middle and bilateral edges of the incision.
Measured: Day1 after surgery
Secondary outcomes (8)
the mechanical pain threshold on the forearm
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 )hand-held Von Frey filaments (North Coast Medical Inc. USA)on the nondominant inner forearm The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 3 measurements at 3, 6, and 9 cm distal to the middle of the antecubital crease
Measured: the day before surgery
the mechanical pain threshold
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 )hand-held Von Frey filaments (North Coast Medical Inc.USA)on the nondominant inner forearm The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 3 measurements at 3, 6, and 9 cm distal to the middle of the antecubital crease .
Measured: Day1 after surgery
the mechanical pain threshold
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 )hand-held Von Frey filaments (North Coast Medical Inc.USA)on the nondominant inner forearm The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 3 measurements at 3, 6, and 9 cm distal to the middle of the antecubital crease .
Measured: Day2 after surgery
the mechanical pain threshold around the incision
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 ) hand-held Von Frey filaments (North Coast Medical Inc. USA)around the skin incision.The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 6 measurements at 2 cm vertically above and below the middle and bilateral edges of the incision.
Measured: Day2 after surgery
postoperative pain scores
postoperative pain scores was assessed by using numeric rating scales(0-10,0 means"better ',10 means "worst") at 6 time points:1 hours,3 hours,6 hours, 12 hours,24 hours, and 48 hours after the operation. The worst pain score during each interval was recorded.
Measured: up to day2 after surgery
Anxiety scale scores
Anxiety scale scores was assessed by Hamilton Anxiety Scale at three time points:the day before surgery, day1 after surgery and day2 after surgery.
If the total score exceeds 29 points, it may be severe anxiety. If the score exceeds 21 points, there must be obvious anxiety. If the score exceeds 14, there must be anxiety. If it exceeds 7 points, there may be anxiety. If it is less than 6, the patient has no anxiety symptoms.
Measured: up to day2 after surgery
Depression scale scores
Depression scale scores was assessed by Hamilton Depression Scale at three time points:the day before surgery, day1 after surgery and day2 after surgery.
The total score is less than 7 points, normal; 7-17 points, there may be depression. 17-24 points, there must be depression, more than 24 points, severe depression.
Measured: up to day2 after surgery
The hyperalgesic area around the incision
The hyperalgesic area around the surgical incision was measured by the von Frey filament that in postoperative pain threshold testing evoked pain on the opposite side. Stimulation was started far from the surgical incision and moved toward the incision in 0.5 cm steps until the patient reported a distinct change in pain perception. The first point at which the patient reported a more painful, sore or sharp feeling was marked, and the distance to the incision was measured . Finally, we calculated the incidence and extension of peri-incisional mechanical hyperalgesia
Measured: up to day2 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start17 Aug 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016128
- Sponsor's protocol ID
- 2021-0442
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Affiliated Hospital Zhejiang University School of Medicine
- ClinicalTrials.gov ID
- NCT05016128
- Acronym / sponsor ID
- 2021-0442
- Conditions
- Postoperative Hyperalgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 23 Aug 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.
Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Opioid-induced hyperalgesia (OIH) and nociceptive-induced hyperalgesia (NIH) are the two main causes of POH.N-methyl-D-aspartate receptor (NMDAR) activation plays a central role in the development of POH.S-ketamine，which is a NMDA-receptor antagonist,has been on the market in china since 2019.The aim of this study is to evaluate the effects of S-ketamine on POH and chronic postoperative pain after video-assisted thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamine | Experimental | Drug: S-ketaminea 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery |
| Saline | Placebo comparator | Drug: salinea 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status class I-III.
- elective single-port video-assisted thoracic surgery under general
Key exclusion criteria (12 listed)
- a history of thoracic surgery
- a history of chronic pain
- ongoing pain treatment
- opioid drug or alcohol abuse
- a history of allergy to anesthetics
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 |
|---|---|---|
| S-ketamineAlso: esketamineS-ketamine is used for preventing postoperative hyperalgesia,thus reducing the patient's acute postoperative pain | Drug | S-ketamine |
| salineAlso: 0.9%salinesaline is used for control | Drug | Saline |
Primary outcome
the mechanical pain threshold around the incision
Time frame: Day1 after surgery
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 ) hand-held Von Frey filaments (North Coast Medical Inc.USA)around the skin incision.The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 6 measurements at 2 cm vertically above and below the middle and bilateral edges of the incision.
8 secondary outcomes
the mechanical pain threshold on the forearm
Time frame: the day before surgery
the mechanical pain threshold
Time frame: Day1 after surgery
the mechanical pain threshold
Time frame: Day2 after surgery
the mechanical pain threshold around the incision
Time frame: Day2 after surgery
postoperative pain scores
Time frame: up to day2 after surgery
Anxiety scale scores
Time frame: up to day2 after surgery
Depression scale scores
Time frame: up to day2 after surgery
The hyperalgesic area around the incision
Time frame: up to day2 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-ketamine and saline in people with Postoperative Hyperalgesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LiNa Yu, doctor (13958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mechanical pain threshold around the incision (time frame: Day1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.