Pain, PostoperativePhase 4KEPOBANCT03389022
Ketamine for Postoperative Pain in Bariatric Surgery
A Phase 4 study testing Ketamine and Saline in people with Pain, Postoperative and Bariatric Surgery Candidate, run by Lithuanian University of Health Sciences.
Trial summary
The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Bariatric Surgery Candidate
- What is being tested?
- Ketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2015to 6 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- II or III The American Society of Anesthesiologists (ASA) physical status
- age > 18 years
- bariatric surgery with general remifentanil anesthesia
Who cannot join
- anamnesis of using opioids for the treatment of chronic pain
- opioid dependence
- younger than 18 years
About this study
Official title: The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.
Read the detailed description
Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.
- Conditions
- Pain, Postoperative, Bariatric Surgery Candidate
- Being tested
- Ketamine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine hydrochloride
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
SalineDrug
Also called Sodium chloride
Intravenous injection given pre-incisional in the operating room.
KetamineDrug
Also called Ketamine hydrochloride
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
KetamineDrug
Also called Ketamine hydrochloride
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
KetamineDrug
Also called Ketamine hydrochloride
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Treatment1 | Active comparator | 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. Receives: Drug: Ketamine |
| Treatment2 | Active comparator | 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. Receives: Drug: Ketamine |
| Treatment3 | Active comparator | 0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room. Receives: Drug: Ketamine |
| Control | Placebo comparator | The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room. Receives: Drug: Saline |
| Treatment4 | Active comparator | 0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours. Postoperative pain was treated with boluses of i.v. morphine (3 mg) at 3 min. intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10). After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.
Measured: On the first postoperative day
Postoperative morphine requirements
Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
Measured: On the first postoperative day
Secondary outcomes (2)
Incidence of side effects
Incidence of side effects will be recorded in both groups on the first postoperative day.
Measured: On the first postoperative day
Patients' satisfaction with postoperative analgesia
Patients' satisfaction with postoperative analgesia will be recorded in both groups on the second postoperative day.The subject could express their level of satisfaction in five possible levels, from "very satisfied" to "very dissatisfied".
Measured: On the second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start22 Jul 2015
- Primary completion30 Mar 2017
- Study completion6 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greta Kasputytė, Lithuanian University of Health Sciences
- Investigators
- Aurika Karbonskienė, MDPhDAssProf, Study chair, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389022
- Sponsor's protocol ID
- BEC-MF-713
- Acronym
- KEPOBA
- Status last verified
- Nov 2021
- First submitted
- 14 Dec 2017
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03389022
- Acronym / sponsor ID
- KEPOBA / BEC-MF-713
- Conditions
- Pain, Postoperative, Bariatric Surgery Candidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 6 Jun 2023 (estimated)
- First posted
- 3 Jan 2018 (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 aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.
Detailed description
Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment1 | Active comparator | Drug: Ketamine0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. |
| Treatment2 | Active comparator | Drug: Ketamine0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room. |
| Treatment3 | Active comparator | Drug: Ketamine0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room. |
| Control | Placebo comparator | Drug: SalineThe same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room. |
| Treatment4 | Active comparator | Drug: Ketamine0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- II or III The American Society of Anesthesiologists (ASA) physical status
- age > 18 years
- bariatric surgery with general remifentanil anesthesia
Key exclusion criteria (3 listed)
- anamnesis of using opioids for the treatment of chronic pain
- opioid dependence
- younger than 18 years
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 |
|---|---|---|
| KetamineAlso: Ketamine hydrochloride0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room. | Drug | Treatment1 |
| SalineAlso: Sodium chlorideIntravenous injection given pre-incisional in the operating room. | Drug | Control |
| KetamineAlso: Ketamine hydrochloride0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room. | Drug | Treatment2 |
| KetamineAlso: Ketamine hydrochloride0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room. | Drug | Treatment3 |
| KetamineAlso: Ketamine hydrochloride0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room. | Drug | Treatment4 |
Primary outcome
Postoperative pain intensity
Time frame: On the first postoperative day
Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours. Postoperative pain was treated with boluses of i.v. morphine (3 mg) at 3 min. intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10). After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.
Postoperative morphine requirements
Time frame: On the first postoperative day
Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
2 secondary outcomes
Incidence of side effects
Time frame: On the first postoperative day
Patients' satisfaction with postoperative analgesia
Time frame: On the second postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 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.
Aurika Karbonskienė, MDPhDAssProf study chair
Lithuanian University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Saline in people with Pain, Postoperative and Bariatric Surgery Candidate, run by Lithuanian University of Health Sciences.
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 3 inclusion and 3 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Postoperative pain intensity (time frame: On the first postoperative day). The study lists 2 primary outcomes in all. 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 22 Nov 2021.