Intrathecal MorphineNCT05439564
Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
A study testing Dexmedetomidine and Morphine in people with Intrathecal Morphine and Intrathecal Morphine-dexmedetomidine Combination, run by Tanta University at 1 site in Egypt.
Trial summary
Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control
- What is being tested?
- Dexmedetomidine and Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 30 Jan 2023
- Phase
- Interventional
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia
Who cannot join
- Patients who had bleeding disorders
- Patients who had heart, liver, or renal failure
- Patients who had systemic infections or infections of their injection sites
- Patients with a known allergy to study
- Patients who had 2nd or 3rd-degree heart block
- Those with low back pain or other back problems
Show all 9Show fewer
- History of drug or alcohol abuse
- Body mass index (BMI) > 30 kg\m2
- Patients with psychiatric illnesses that would interfere with perception and assessment of pain.
Trial locations and contacts
1 site in 1 country.
About this study
Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. The increased sensitivity of elderly patients to drugs makes it necessary to choose postoperative analgesia agents and methods that have minimal side effects.
Intrathecal injection of morphine to provide postoperative analgesia during the initial 24-h after the operation is a widely used technique, however, opioid therapy is limited because of the side effects (hypotension, pruritus, nausea, urinary retention, respiratory depression) and intolerance.
Read more
Alpha-2 adrenergic agonists (clonidine and dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia.
Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system.
The rationale for combining analgesics that produce similar therapeutic effects or synergistic interactions is to accentuate the analgesic efficacy and decrease the side effects by permitting dose reduction of each agent. Human studies on the antinociceptive effects of co-administrated intrathecal morphine (ITM) and dexmedetomidine in postoperative pain are still few.
On the other hand, Abdel-Ghaffar et al., results do not support improved analgesia with the combination of intrathecal morphine and dexmedetomidine, despite the absence of significant adverse effects.
We hypothesized that the addition of dexmedetomidine to ITM would improve the quality of perioperative pain control and decrease the side effects of postoperative systemic opioid use.
Read the detailed description
105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia will be included in this study.
105 Patients will be randomly allocated into three equal groups (35 patients each):
- Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
- Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine
Measurements:
- Demographic data as age, BMI, ASA status, duration of surgery
- During surgery, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) will be recorded at the 1st, 5th, 15th, 30th, and 60th minutes.
- Postoperative pain severity assessed by the visual analog score for pain at rest (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Accordingly, the patient is requested to verbally express his degree of pain using this scale. Patients with the visual analog score≥ 4 will be received 3 mg morphine IV and will be recorded. Patients who complained of pain (the visual analog score< 3) and needed analgesics will be treated intravenous infusion every six to eight hours with Diclofenac Na(75mg).
- The total dose of morphine used postoperatively will be observed and recorded for the 1st, 2nd, 6th, 12th, and 24th postoperative hours.
- The period from the moment the intrathecal injection will be made postoperatively until the first analgesic became necessary will be recorded
- Any recorded postoperative complication as sedation, nausea and vomiting, respiratory depression.
- The patient's level of sedation will be assessed at the same time points using Ramsay Sedation Scale (score 3-4 mean adequate sedation). (17)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called morphine
Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
MorphineDrug
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
DexmedetomidineDrug
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Group morphine | Placebo comparator | Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine. Receives: Drug: Morphine |
| Group morphine-Dex | Active comparator | Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine. Receives: Drug: Dexmedetomidine; Drug: Morphine |
| Group Dex | Active comparator | Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset of pain
The onset of pain is defined as VAS ≥ 4 within 24 hours
Measured: upto 24 hours postoperative
Secondary outcomes (3)
Postoperative pain severity
VAS ≥ 4 within 24 hours
Measured: upto 24 hours postoperative
The amount of additional analgesic required
Patients with VAS ≥ 4 will be received 3 mg morphine IV. Patients who complained of pain (VAS < 3) and needed analgesics will be treated with intravenous infusion every six to eight hours with Diclofenac Na(75mg).
Measured: upto 24 hours postoperative
Postoperative complications
the incidence of PONV, respiratory depression, and itching.
Measured: upto 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal MorphineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Faheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439564
- Sponsor's protocol ID
- Intrathecal morphine-precedex
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2022
- Last updated
- 24 Nov 2023
- Results posted
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05439564
- Acronym / sponsor ID
- Intrathecal morphine-precedex
- Conditions
- Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 30 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.
Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. The increased sensitivity of elderly patients to drugs makes it necessary to choose postoperative analgesia agents and methods that have minimal side effects.
Intrathecal injection of morphine to provide postoperative analgesia during the initial 24-h after the operation is a widely used technique, however, opioid therapy is limited because of the side effects (hypotension, pruritus, nausea, urinary retention, respiratory depression) and intolerance.
Alpha-2 adrenergic agonists (clonidine and dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia.
Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system.
The rationale for combining analgesics that produce similar therapeutic effects or synergistic interactions is to accentuate the analgesic efficacy and decrease the side effects by permitting dose reduction of each agent. Human studies on the antinociceptive effects of co-administrated intrathecal morphine (ITM) and dexmedetomidine in postoperative pain are still few.
On the other hand, Abdel-Ghaffar et al., results do not support improved analgesia with the combination of intrathecal morphine and dexmedetomidine, despite the absence of significant adverse effects.
We hypothesized that the addition of dexmedetomidine to ITM would improve the quality of perioperative pain control and decrease the side effects of postoperative systemic opioid use.
Detailed description
105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia will be included in this study.
105 Patients will be randomly allocated into three equal groups (35 patients each):
- Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
- Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine
Measurements:
- Demographic data as age, BMI, ASA status, duration of surgery
- During surgery, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) will be recorded at the 1st, 5th, 15th, 30th, and 60th minutes.
- Postoperative pain severity assessed by the visual analog score for pain at rest (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Accordingly, the patient is requested to verbally express his degree of pain using this scale. Patients with the visual analog score≥ 4 will be received 3 mg morphine IV and will be recorded. Patients who complained of pain (the visual analog score< 3) and needed analgesics will be treated intravenous infusion every six to eight hours with Diclofenac Na(75mg).
- The total dose of morphine used postoperatively will be observed and recorded for the 1st, 2nd, 6th, 12th, and 24th postoperative hours.
- The period from the moment the intrathecal injection will be made postoperatively until the first analgesic became necessary will be recorded
- Any recorded postoperative complication as sedation, nausea and vomiting, respiratory depression.
- The patient's level of sedation will be assessed at the same time points using Ramsay Sedation Scale (score 3-4 mean adequate sedation). (17)
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 |
|---|---|---|
| Group morphine | Placebo comparator | Drug: MorphineGroup morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine. |
| Group morphine-Dex | Active comparator | Drug: Dexmedetomidine, Drug: MorphineGroup morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine. |
| Group Dex | Active comparator | Drug: DexmedetomidineGroup Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia
Key exclusion criteria (9 listed)
- Patients who had bleeding disorders
- Patients who had heart, liver, or renal failure
- Patients who had systemic infections or infections of their injection sites
- Patients with a known allergy to study
- Patients who had 2nd or 3rd-degree heart block
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 |
|---|---|---|
| DexmedetomidineAlso: morphineGroup morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine. | Drug | Group morphine-Dex |
| MorphineGroup morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine. | Drug | Group morphine, Group morphine-Dex |
| DexmedetomidineGroup Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine. | Drug | Group Dex |
Primary outcome
The onset of pain
Time frame: upto 24 hours postoperative
The onset of pain is defined as VAS ≥ 4 within 24 hours
3 secondary outcomes
Postoperative pain severity
Time frame: upto 24 hours postoperative
The amount of additional analgesic required
Time frame: upto 24 hours postoperative
Postoperative complications
Time frame: upto 24 hours postoperative
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 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Morphine in people with Intrathecal Morphine and Intrathecal Morphine-dexmedetomidine Combination, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 9 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 Nov 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 Egypt. 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.
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?
The onset of pain (time frame: upto 24 hours postoperative). 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 24 Nov 2023.