Postoperative PainPhase 4NCT02653651
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
A Phase 4 study testing Ketamine and Lidocaine in people with Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketamine and Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2016to Jul 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>/=18)
- male or female
- Undergoing elective open nephrectomy
- General anesthesia
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Who cannot join
- Pregnancy and breastfeeding
- Cognitively impaired (by history)
- Subject with a history of psychosis
- Subject known to have significant hepatic disease
- History of previous cardiac arrhythmia
- Subject for whom opioids or ketamine are contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study
Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.
Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.
The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.
Read the detailed description
Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.
- Conditions
- Postoperative Pain
- Keywords
- Ketamine, Lidocaine, Nephrectomy, Chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine infused at 0.1 mg/kg/hour
LidocaineDrug
Lidocaine infused at 1 mg/kg/hour
PlaceboDrug
Also called Saline
An equal volume of saline
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Ketamine infused at 0.1 mg/kg/hour Receives: Drug: Ketamine |
| Lidocaine | Experimental | Lidocaine infused at 1 mg/kg/hour Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | An equal volume of saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
the total amount of morphine consumed during follow up period
Measured: 24 hours
Secondary outcomes (3)
Postoperative nausea and vomiting using a Verbal Rating Scale
Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale
Measured: 48 hours
Functional recovery assessed by 6 minute walk test (6MWT)
Measured: the fourth postoperative morning
chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali JENDOUBI, University Tunis El Manar
- Investigators
- Ali JENDOUBI, Principal investigator, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653651
- Sponsor's protocol ID
- UTuniselmanar
- Status last verified
- Jul 2016
- First submitted
- 1 Jan 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02653651
- Acronym / sponsor ID
- UTuniselmanar
- Conditions
- Postoperative Pain
- Keywords
- Ketamine, Lidocaine, Nephrectomy, Chronic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- 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.
Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.
Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.
The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.
Detailed description
Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineKetamine infused at 0.1 mg/kg/hour |
| Lidocaine | Experimental | Drug: LidocaineLidocaine infused at 1 mg/kg/hour |
| Placebo | Placebo comparator | Drug: PlaceboAn equal volume of saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>/=18)
- male or female
- Undergoing elective open nephrectomy
- General anesthesia
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Key exclusion criteria (6 listed)
- Pregnancy and breastfeeding
- Cognitively impaired (by history)
- Subject with a history of psychosis
- Subject known to have significant hepatic disease
- History of previous cardiac arrhythmia
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 |
|---|---|---|
| KetamineKetamine infused at 0.1 mg/kg/hour | Drug | Ketamine |
| LidocaineLidocaine infused at 1 mg/kg/hour | Drug | Lidocaine |
| PlaceboAlso: SalineAn equal volume of saline | Drug | Placebo |
Primary outcome
Total opioid consumption
Time frame: 24 hours
the total amount of morphine consumed during follow up period
3 secondary outcomes
Postoperative nausea and vomiting using a Verbal Rating Scale
Time frame: 48 hours
Functional recovery assessed by 6 minute walk test (6MWT)
Time frame: the fourth postoperative morning
chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)
Time frame: At 3 months
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 28 Jul 2016.
- 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.
Ali JENDOUBI principal investigator
University Tunis El Manar
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 Ketamine and Lidocaine in people with Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
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 28 Jul 2016. 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 Tunisia. 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?
Total opioid consumption (time frame: 24 hours). 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 28 Jul 2016.