Postoperative PainPhase 4NCT03058341
Effect of Total Intravenous Anaesthesia With Propofol on Postoperative Pain After Bilateral Third Molar Surgery
A Phase 4 study testing propofol and Sevoflurane in people with Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Some of the advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, better wake up profile and a more… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Dec 2016to 30 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I to III
- Age 18 to 80 years old
- Scheduled for elective extraction of impacted bilateral third molar teeth under general anaesthesia in Queen Mary hospital.
Who cannot join
- Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol.
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- Patients with liver dysfunction (Plasma bilirubin over 34 micromol/L, INR over 1.7, ALT and AST over 100U/L)
- Impaired or retarded mental state
- BMI > 35kg/m2
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- History of chronic pain
- Pregnancy
- Local infection
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Total Intravenous Anaesthesia With Propofol on Postoperative Pain After Third Molar Surgery: A Double-Blind Randomized Controlled Trial
Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Some of the advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, better wake up profile and a more favourable intracranial physiology. However, the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are some reasons that preclude more common use.
Postoperative dental pain produces an inflammatory pain model. Since propofol has anti-inflammatory effects, it may have significant analgesic effects in patients undergoing dental surgery. To the best of our knowledge, there are no randomized controlled trials comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative pain scores, analgesic consumption, and adverse effects in patients undergoing dental surgery. This will help determine whether propofol may be a useful analgesic adjunct in dental surgery.
Read the detailed description
Preoperative care
Assessment will be done at the preadmission clinic or at the general ward. Fasting for patients will start at midnight before operation. Sedative premedication will not be prescribed.
Anaesthesia and intraoperative care
Group S
Patients from group S will be anaesthetized according to the following protocol:
On arrival to the operation theatre, a 20 or 22 gauge intravenous cannula will be inserted. Standard monitoring with pulse oximeter, non-invasive blood pressure, and three lead electrocardiogram will be applied prior to induction. Non-invasive blood pressure will be checked at least every 5 minutes throughout the operation.
Propofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required.
Intravenous phenylephrine, ephedrine or fluid administration with colloid or crystalloid will be given at the discretion of the anaesthesiologist for management of hypotension. Hypertension or tachycardia will be managed by titrating the remifentanil infusion up to 0.25mcg/kg/min or sevoflurane up to 1.5 MAC. Intravenous anti hypertensive agents such as beta blockers (eg. esmolol, labetolol), hydralazine, glyceryl trinitrate, and phentolamine can be given if hypertension persists.
Thermal blanket will be used with the aim of keeping a core temperature of 35.5-37.5 degrees Celsius. Ondansetron 4mg IV can be given 30 minutes before end of surgery.
Sevoflurane and remifentanil infusion will be switched off at the end of the procedure. Reversal of muscle relaxation can be obtained if required with neostigmine 50mcg/kg IV and atropine 20mcg/kg IV after the operation. Patients will subsequently be transferred to the post anaesthetic care unit (PACU) for monitoring for at least 30 minutes.
Group P
Patients in group P will be anaesthetized according to the following protocol:
Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.
Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Level of anaesthesia will be titrated to produce a BIS value of between 40-60. As with patients in group S, remifentanil will be infused at a rate of between 0.1-0.25mcg/kg/min.
Analgesic modalities and pain assessment
Both groups (Groups S and P)
Dental surgeon will provide local infiltration with 2.7ml of 2% lignocaine with 1:80,000 adrenaline around the base of the gum of each third molar tooth. Morphine sulphate at a bolus dose of 0.025-0.075 mg/kg will be given intravenously before skin incision.
Resting pain scores will be checked every 5 minutes in the post anaesthetic care unit. 2mg boluses of intravenous morphine sulphate will be given every 5 minutes until the NRS pain score is less than 4/10. Respiratory rate, oxygen saturation, Ramsay sedation scores, blood pressure and heart rate will be monitored every 5 minutes while the patient is in the post anaesthetic care unit.
When the patient resumes fluid diet on postoperative day 0, oral paracetamol 500mg q6h and oral dihydrocodeine 30mg q6h will be prescribed on an as needed basis when NRS pain score is more than 3/10 for three days. Both analgesics will be given together.
In the ward, pain related parameters like the numerical rating scales (NRS) pain scores at rest and mouth opening, and side effects will also be recorded every 1 hour for 6 hours, and then once every 4 hours. Patients will be given a diary to record NRS pain scores at rest and with mouth opening, analgesic consumption, and side effects at 24th, 48th and 72nd hour after operation. Global pain satisfaction using a scale of 0-10 (0 being least satisfied and 10 being most satisfied) will be recorded on postoperative day 3.
Monitoring of vital signs will be at the discretion of the attending dental surgeon once the patient returns to ward, and final hospital discharge will also be determined by the attending dental surgeon.
A brief home telephone interview will be conducted at 3 months to assess the incidence of chronic pain. The severity of pain, if present, would be recorded using NRS at rest and on mouth opening from 0-10.
- Conditions
- Postoperative Pain
- Being tested
- propofol, Sevoflurane
- Keywords
- postoperative pain, propofol, TIVA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.
SevofluraneDrug
Propofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Sham comparator | Patients will be anaesthetized by inhalational anaesthesia using sevoflurane. Receives: Drug: Sevoflurane |
| Group P | Experimental | Patients will be anaesthetized using total intravenous propofol. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
measure pain scores at rest and mouth opening using numeral rating scale
Measured: up to postoperative day 3
Secondary outcomes (7)
analgesic consumption
record analgesic consumption base on patient drug record
Measured: up to postoperative day 3
side effects of analgesics used
pruritus, dizziness, nausea, vomiting, constipation etc.
Measured: up to postoperative day 3
intraoperative vital signs
blood pressure
Measured: during surgery
intraoperative vital signs
heart rate
Measured: during surgery
intraoperative vital signs
oxygen saturation
Measured: during surgery
presence of persistent pain
presence of chronic pain after surgery (Yes or No), and severity of pain using NRS 0-10 if pain is present
Measured: 3 months after surgery
severity of persistent pain
severity of pain using NRS 0-10 if pain is present
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start23 Dec 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
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 The University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the first group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane. The patients in the second group (P) will be anaesthetized using total intravenous propofol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
- Investigators
- Stanley SC Wong, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058341
- Sponsor's protocol ID
- UW16-554
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Total Intravenous Anaesthesia With Propofol on Postoperative Pain After Third Molar Surgery: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03058341
- Acronym / sponsor ID
- UW16-554
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, propofol, TIVA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 20 Feb 2017 (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.
Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Some of the advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, better wake up profile and a more favourable intracranial physiology. However, the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are some reasons that preclude more common use.
Postoperative dental pain produces an inflammatory pain model. Since propofol has anti-inflammatory effects, it may have significant analgesic effects in patients undergoing dental surgery. To the best of our knowledge, there are no randomized controlled trials comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative pain scores, analgesic consumption, and adverse effects in patients undergoing dental surgery. This will help determine whether propofol may be a useful analgesic adjunct in dental surgery.
Detailed description
Preoperative care
Assessment will be done at the preadmission clinic or at the general ward. Fasting for patients will start at midnight before operation. Sedative premedication will not be prescribed.
Anaesthesia and intraoperative care
Group S
Patients from group S will be anaesthetized according to the following protocol:
On arrival to the operation theatre, a 20 or 22 gauge intravenous cannula will be inserted. Standard monitoring with pulse oximeter, non-invasive blood pressure, and three lead electrocardiogram will be applied prior to induction. Non-invasive blood pressure will be checked at least every 5 minutes throughout the operation.
Propofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required.
Intravenous phenylephrine, ephedrine or fluid administration with colloid or crystalloid will be given at the discretion of the anaesthesiologist for management of hypotension. Hypertension or tachycardia will be managed by titrating the remifentanil infusion up to 0.25mcg/kg/min or sevoflurane up to 1.5 MAC. Intravenous anti hypertensive agents such as beta blockers (eg. esmolol, labetolol), hydralazine, glyceryl trinitrate, and phentolamine can be given if hypertension persists.
Thermal blanket will be used with the aim of keeping a core temperature of 35.5-37.5 degrees Celsius. Ondansetron 4mg IV can be given 30 minutes before end of surgery.
Sevoflurane and remifentanil infusion will be switched off at the end of the procedure. Reversal of muscle relaxation can be obtained if required with neostigmine 50mcg/kg IV and atropine 20mcg/kg IV after the operation. Patients will subsequently be transferred to the post anaesthetic care unit (PACU) for monitoring for at least 30 minutes.
Group P
Patients in group P will be anaesthetized according to the following protocol:
Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.
Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Level of anaesthesia will be titrated to produce a BIS value of between 40-60. As with patients in group S, remifentanil will be infused at a rate of between 0.1-0.25mcg/kg/min.
Analgesic modalities and pain assessment
Both groups (Groups S and P)
Dental surgeon will provide local infiltration with 2.7ml of 2% lignocaine with 1:80,000 adrenaline around the base of the gum of each third molar tooth. Morphine sulphate at a bolus dose of 0.025-0.075 mg/kg will be given intravenously before skin incision.
Resting pain scores will be checked every 5 minutes in the post anaesthetic care unit. 2mg boluses of intravenous morphine sulphate will be given every 5 minutes until the NRS pain score is less than 4/10. Respiratory rate, oxygen saturation, Ramsay sedation scores, blood pressure and heart rate will be monitored every 5 minutes while the patient is in the post anaesthetic care unit.
When the patient resumes fluid diet on postoperative day 0, oral paracetamol 500mg q6h and oral dihydrocodeine 30mg q6h will be prescribed on an as needed basis when NRS pain score is more than 3/10 for three days. Both analgesics will be given together.
In the ward, pain related parameters like the numerical rating scales (NRS) pain scores at rest and mouth opening, and side effects will also be recorded every 1 hour for 6 hours, and then once every 4 hours. Patients will be given a diary to record NRS pain scores at rest and with mouth opening, analgesic consumption, and side effects at 24th, 48th and 72nd hour after operation. Global pain satisfaction using a scale of 0-10 (0 being least satisfied and 10 being most satisfied) will be recorded on postoperative day 3.
Monitoring of vital signs will be at the discretion of the attending dental surgeon once the patient returns to ward, and final hospital discharge will also be determined by the attending dental surgeon.
A brief home telephone interview will be conducted at 3 months to assess the incidence of chronic pain. The severity of pain, if present, would be recorded using NRS at rest and on mouth opening from 0-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the first group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane. The patients in the second group (P) will be anaesthetized using total intravenous propofol.
| Arm | Type | Receives |
|---|---|---|
| Group S | Sham comparator | Drug: SevofluranePatients will be anaesthetized by inhalational anaesthesia using sevoflurane. |
| Group P | Experimental | Drug: propofolPatients will be anaesthetized using total intravenous propofol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I to III
- Age 18 to 80 years old
- Scheduled for elective extraction of impacted bilateral third molar teeth under general anaesthesia in Queen Mary hospital.
Key exclusion criteria (10 listed)
- Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol.
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
- Patients with liver dysfunction (Plasma bilirubin over 34 micromol/L, INR over 1.7, ALT and AST over 100U/L)
- Impaired or retarded mental state
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 |
|---|---|---|
| propofolMonitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%. | Drug | Group P |
| SevofluranePropofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required. | Drug | Group S |
Primary outcome
pain score
Time frame: up to postoperative day 3
measure pain scores at rest and mouth opening using numeral rating scale
7 secondary outcomes
analgesic consumption
Time frame: up to postoperative day 3
side effects of analgesics used
Time frame: up to postoperative day 3
intraoperative vital signs
Time frame: during surgery
intraoperative vital signs
Time frame: during surgery
intraoperative vital signs
Time frame: during surgery
presence of persistent pain
Time frame: 3 months after surgery
severity of persistent pain
Time frame: 3 months after surgery
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 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Stanley SC Wong, MBBS principal investigator
The University of Hong Kong
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 propofol and Sevoflurane in people with Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 10 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 7 Jul 2020. 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 Hong Kong. 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?
pain score (time frame: up to postoperative day 3). 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 7 Jul 2020.