Postoperative PainPhase 4NCT05414006
Effect of S-ketamine in Cesarean Section Combined Anesthesia
A Phase 4 study testing S-ketamine in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia. Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- S-ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2022to 5 Sep 2022
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA status I-III
- Age 20 to 45
- 37-42 weeks gestation
- undergo elective cesarean section with subarachnoid anesthesia
- participate in this study and sign informed consent
Who cannot join
- Patients with contraindications for cesarean section
- Patients with contraindications of combined spinal and epidural anesthesia
- Patients with severe systemic disease
- Alcoholism and long-term use of anti-inflammatory and analgesic drugs
- Patients who were unable to cooperate or refused to participate in the trial
- Patients with contraindications to esketamine and hydromorphone
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.
Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation
- Conditions
- Postoperative Pain
- Being tested
- S-ketamine
- Keywords
- S-ketamine, Cesarean Section, hyperalgesia
- Medical subject headings
- Pain, Postoperative, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
Also called Patient controlled analgesia
S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group E1 | Experimental | S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml Receives: Drug: S-ketamine |
| Group E2 | Experimental | S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml Receives: Drug: S-ketamine |
| Group C1 | Placebo comparator | placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml Receives: Drug: S-ketamine |
| Group C2 | Placebo comparator | placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml Receives: Drug: S-ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score (NRS socre) at 0-24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From ending of the surgery to 24 hours postoperatively
Pain score (NRS socre) at 0-6 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From ending of the surgery to 6 hours postoperatively
Pain score (NRS socre) at 6-12 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From 6 hours postoperatively to 12 hours postoperatively
Pain score (NRS socre) at 12-24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From 12 hours postoperatively to 24 hours postoperatively
Secondary outcomes (5)
The number of patient controlled analgesia pump pressed
When the patients felt pain, the patient controlled analgesia pump can be pressed once
Measured: 0-48 hours postoperatively
Patient controlled analgesia pump analgesic consumption
The amount of the analgesic consumption
Measured: 0-48 hours postoperatively
Pressure pain threshold at 30min after surgery
Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
Measured: Change from baseline to 30 minutes postoperatively
Pressure pain threshold at 24 hours after surgery
Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
Measured: Change from baseline to 30 min postoperatively
Pressure pain tolerance at 30min hours after surgery
Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
Measured: Change from baseline to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start14 Jun 2022
- Primary completion31 Aug 2022
- Study completion5 Sep 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUANG HE, MD, Study director, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414006
- Sponsor's protocol ID
- S-ketamine and CS hyperalgesia
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email
Publications
Zhang J, Sun D, Wang J, Chen J, Chen Y, Shu B, Huang H, Duan G. Exploring the Analgesic Efficacy and mechanisms of low-dose esketamine in pregnant women undergoing cesarean section: A randomized controlled trial. Heliyon. 2024 Jul 30;10(15):e35434. doi: 10.1016/j.heliyon.2024.e35434. eCollection 2024 Aug 15.
PubMed 39170110
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of S-ketamine in Cesarean Section Combined Anesthesia
- ClinicalTrials.gov ID
- NCT05414006
- Acronym / sponsor ID
- S-ketamine and CS hyperalgesia
- Conditions
- Postoperative Pain
- Keywords
- S-ketamine, Cesarean Section, hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 10 Jun 2022 (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.
To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.
Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
| Arm | Type | Receives |
|---|---|---|
| Group E1 | Experimental | Drug: S-ketamineS-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml |
| Group E2 | Experimental | Drug: S-ketamineS-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml |
| Group C1 | Placebo comparator | Drug: S-ketamineplacebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml |
| Group C2 | Placebo comparator | Drug: S-ketamineplacebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA status I-III
- Age 20 to 45
- 37-42 weeks gestation
- undergo elective cesarean section with subarachnoid anesthesia
- participate in this study and sign informed consent
Key exclusion criteria (6 listed)
- Patients with contraindications for cesarean section
- Patients with contraindications of combined spinal and epidural anesthesia
- Patients with severe systemic disease
- Alcoholism and long-term use of anti-inflammatory and analgesic drugs
- Patients who were unable to cooperate or refused to participate in the trial
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: Patient controlled analgesiaS-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively | Drug | Group C1, Group C2, Group E1, Group E2 |
Primary outcome
Maximum pain score (NRS socre) at 0-24 hours postoperatively
Time frame: From ending of the surgery to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 0-6 hours postoperatively
Time frame: From ending of the surgery to 6 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 6-12 hours postoperatively
Time frame: From 6 hours postoperatively to 12 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 12-24 hours postoperatively
Time frame: From 12 hours postoperatively to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
5 secondary outcomes
The number of patient controlled analgesia pump pressed
Time frame: 0-48 hours postoperatively
Patient controlled analgesia pump analgesic consumption
Time frame: 0-48 hours postoperatively
Pressure pain threshold at 30min after surgery
Time frame: Change from baseline to 30 minutes postoperatively
Pressure pain threshold at 24 hours after surgery
Time frame: Change from baseline to 30 min postoperatively
Pressure pain tolerance at 30min hours after surgery
Time frame: Change from baseline to 24 hours postoperatively
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 24 Feb 2023.
- Derived from this study: PubMed 39170110Zhang J, Sun D, Wang J, Chen J, Chen Y, Shu B, Huang H, Duan G. Exploring the Analgesic Efficacy and mechanisms of low-dose esketamine in pregnant women undergoing cesarean section: A randomized controlled trial. Heliyon. 2024 Jul 30;10(15):e35434. doi: 10.1016/j.heliyon.2024.e35434. eCollection 2024 Aug 15.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email
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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.
HUANG HE, MD study director
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S-ketamine in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 6 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 24 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum pain score (NRS socre) at 0-24 hours postoperatively (time frame: From ending of the surgery to 24 hours postoperatively). The study lists 4 primary outcomes in all. 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 NCT05414006, 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 24 Feb 2023.