Postoperative PainPhase 2NCT03549221
Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty
A Phase 2 study testing 0.6 mg 1:1000 epinephrine (0.6 ml) in people with Postoperative Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
Multimodal anesthetic drug injection has been used extensively and the results of many studies suggest that postoperative pain can relief and improve the postoperative satisfaction of patients. Adrenaline is a combination of multimodal anesthetic cocktail to relieve pain. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 0.6 mg 1:1000 epinephrine (0.6 ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteThailand
- Study dates
- 26 Jan 2018to 31 Oct 2018
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary knee osteoarthritis
- Aged between 40 and 80 years
- Must be able to understand and willing to follow instructions
Who cannot join
- Patients unable to undergo anesthesia during surgery by spinal block or adductor block
- Patients with the history of levobupivacaine, etoricoxib drug allergy
- Patients with the history of allergic or nausea vomiting severely when receiving morphine
- Patients with kidney disease who have a creatinine clearance of less than 50 ml/min, cirrhosis, cardiovascular disease, stroke, poorly controlled hypertension
- Patients with the history of venous thrombosis
- Patients with complications during surgery such as torn ligaments
- Patients who refuse to participate in the research.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chaturong Pornrattanamaneewong
Bangkok, 10700
Rapeepat Narkbunnam, MD, 6681-9351669, mai_parma@hotmail.com
Keerati Chareancholvanivh, MD, 6681-8188568, keesi93@gmail.com
About this study
Official title: Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial
Multimodal anesthetic drug injection has been used extensively and the results of many studies suggest that postoperative pain can relief and improve the postoperative satisfaction of patients. Adrenaline is a combination of multimodal anesthetic cocktail to relieve pain. It is believed that Adrenaline causes vasoconstriction, reduces absorption of anesthetic drug into the system circulation. Currently, a comparative study on the effect of pain reduction of Adrenaline injection in the anesthetic cocktail is relatively low. There are different doses in each institution. In addition, the use of new anesthetic is Levobupivacaine that has more vasoconstrictive effect compare with traditional Bupivacaine. It also reduces the side effects of systemic and cardiotoxic effect. Therefore, the investigators think that It may not be necessary to mix Adrenaline in the multimodal anesthetic drug. Levobupivacaine already to avoid the potential side effects of Adrenaline.
Read the detailed description
The patients will be divided into two groups. In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml. The outcome research assistant who collects data was blinded to the treatment groups. Patients will be treated with the routine standard regimen for total knee arthroplasty. Surgeons will use same surgical techniques through a standard medial parapatellar approach. In addition, standardized posterior-stabilized TKA (Zimmer Nexgen LPS flex) was used in all patients. After bone cutting before inserting the actual implant, the assistant scrub nurse in the operating room will open the envelope that the patient was classified in group 1 or group 2 and perform mixing according to the prescribed medication. The doctor who undergoes surgery was blinded. The anesthetic cocktail was divided into 4 parts 25 ml each and it was injected into 4 areas. First 25 ml cocktail was injected into the posterior capsule (P), posteromedial (PM) and posterolateral capsule (PL). The second part was injected into the medial gutter (M). The third part was injected into the lateral gutter and the forth part was injected into quadriceps muscle, retinacula tissues, pes anserinus, suprapatellar and infrapatellar fat pads (A). During the first 48 hours, all patients received intravenous morphine prn for pain, as well as dynastat, Tylenol with codeine, as required, for control of pain. After 48 hours, the pain was controlled by oral intravenous morphine and medication as requires until the patient was discharged from the hospital.
The primary outcome measure was the severity of postoperative pain during the first 48 hours after surgery. The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively. Secondary outcome measures compared the consumption of intravenous morphine, which was measured every six hours in 48 hours after surgery. Additionally, blood loss in the drain at 24, 48 hours was recorded. Any complications following surgery were recorded.
- Conditions
- Postoperative Pain
- Being tested
- 0.6 mg 1:1000 epinephrine (0.6 ml)
- Keywords
- total knee arthroplasty, multimodal anesthetic cocktail, adrenaline, morphine consumption, blood loss, Levobupivacaine
- Medical subject headings
- Pain, Postoperative, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.6 mg 1:1000 epinephrine (0.6 ml)Drug
Also called 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml)
In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml.
| Study group | Role | What they receive |
|---|---|---|
| MAC with adrenaline | Experimental | the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml. Receives: Drug: 0.6 mg 1:1000 epinephrine (0.6 ml) |
| MAC without adrenaline | No intervention | the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of postoperative pain
The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively.
Measured: The first 48 hours after surgery
Secondary outcomes (2)
the consumption of intravenous morphine
the consumption of intravenous morphine, which was measured every six hours
Measured: The first 48 hours after surgery
blood loss in the drain
blood loss in the radivac drain
Measured: at 24, 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start26 Jan 2018
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
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.
- More trials run by Mahidol UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaturong Pornrattanamaneewong, Mahidol University
- Investigators
- Keerati Chareancholvanich, MD, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549221
- Sponsor's protocol ID
- 696/2560
- Status last verified
- Jun 2018
- First submitted
- 25 May 2018
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03549221
- Acronym / sponsor ID
- 696/2560
- Conditions
- Postoperative Pain
- Keywords
- total knee arthroplasty, multimodal anesthetic cocktail, adrenaline, morphine consumption, blood loss, Levobupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 7 Jun 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.
Multimodal anesthetic drug injection has been used extensively and the results of many studies suggest that postoperative pain can relief and improve the postoperative satisfaction of patients. Adrenaline is a combination of multimodal anesthetic cocktail to relieve pain. It is believed that Adrenaline causes vasoconstriction, reduces absorption of anesthetic drug into the system circulation. Currently, a comparative study on the effect of pain reduction of Adrenaline injection in the anesthetic cocktail is relatively low. There are different doses in each institution. In addition, the use of new anesthetic is Levobupivacaine that has more vasoconstrictive effect compare with traditional Bupivacaine. It also reduces the side effects of systemic and cardiotoxic effect. Therefore, the investigators think that It may not be necessary to mix Adrenaline in the multimodal anesthetic drug. Levobupivacaine already to avoid the potential side effects of Adrenaline.
Detailed description
The patients will be divided into two groups. In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml. The outcome research assistant who collects data was blinded to the treatment groups. Patients will be treated with the routine standard regimen for total knee arthroplasty. Surgeons will use same surgical techniques through a standard medial parapatellar approach. In addition, standardized posterior-stabilized TKA (Zimmer Nexgen LPS flex) was used in all patients. After bone cutting before inserting the actual implant, the assistant scrub nurse in the operating room will open the envelope that the patient was classified in group 1 or group 2 and perform mixing according to the prescribed medication. The doctor who undergoes surgery was blinded. The anesthetic cocktail was divided into 4 parts 25 ml each and it was injected into 4 areas. First 25 ml cocktail was injected into the posterior capsule (P), posteromedial (PM) and posterolateral capsule (PL). The second part was injected into the medial gutter (M). The third part was injected into the lateral gutter and the forth part was injected into quadriceps muscle, retinacula tissues, pes anserinus, suprapatellar and infrapatellar fat pads (A). During the first 48 hours, all patients received intravenous morphine prn for pain, as well as dynastat, Tylenol with codeine, as required, for control of pain. After 48 hours, the pain was controlled by oral intravenous morphine and medication as requires until the patient was discharged from the hospital.
The primary outcome measure was the severity of postoperative pain during the first 48 hours after surgery. The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively. Secondary outcome measures compared the consumption of intravenous morphine, which was measured every six hours in 48 hours after surgery. Additionally, blood loss in the drain at 24, 48 hours was recorded. Any complications following surgery were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC with adrenaline | Experimental | Drug: 0.6 mg 1:1000 epinephrine (0.6 ml)the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml. |
| MAC without adrenaline | No intervention | –the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary knee osteoarthritis
- Aged between 40 and 80 years
- Must be able to understand and willing to follow instructions
Key exclusion criteria (7 listed)
- Patients unable to undergo anesthesia during surgery by spinal block or adductor block
- Patients with the history of levobupivacaine, etoricoxib drug allergy
- Patients with the history of allergic or nausea vomiting severely when receiving morphine
- Patients with kidney disease who have a creatinine clearance of less than 50 ml/min, cirrhosis, cardiovascular disease, stroke, poorly controlled hypertension
- Patients with the history of venous thrombosis
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 |
|---|---|---|
| 0.6 mg 1:1000 epinephrine (0.6 ml)Also: 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml)In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml. | Drug | MAC with adrenaline |
Primary outcome
the severity of postoperative pain
Time frame: The first 48 hours after surgery
The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively.
2 secondary outcomes
the consumption of intravenous morphine
Time frame: The first 48 hours after surgery
blood loss in the drain
Time frame: at 24, 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- 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.
Keerati Chareancholvanich, MD study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.6 mg 1:1000 epinephrine (0.6 ml) in people with Postoperative Pain, run by Mahidol University at 1 site in Thailand.
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 7 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 12 Jun 2018. 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 Thailand. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Chaturong Pornrattanamaneewong, MD (6681-7553977, toonchaturong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the severity of postoperative pain (time frame: The first 48 hours 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 12 Jun 2018.