Postoperative PainPhase 4NCT05588336
Intrathecal Morphine for Thoracoscopic Surgery
A Phase 4 study testing Morphine in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2022to 10 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years old
- ASA class I and II
- Video-assisted thoracoscopic surgery
Who cannot join
- < 18 years old
- ASA class > II
- Serious hepatic, cardiac, renal, metabolic, endocrine diseases
- Coagulation disfunction
- Allergy to any of the study drugs
- Pneumonectomy
- Infection in the lumbar region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection
Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight.
Read the detailed description
Patients who underwent video-assisted thoracic surgery were divided into two groups: 10 mcg/kg and 7 mcg/kg intrathecal morphine for postoperative analgesia. Intraoperative and postoperative hemodynamic variables, postoperative morphine consumption, postoperative pain scores, side effects and additional analgesic requiretment were recorded.
- Conditions
- Postoperative Pain
- Being tested
- Morphine
- Keywords
- postoperative analgesia, pain score, side effect, morphine, intrathecal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
In the literature, intrathecal morphine doses were applied according to the patients' actual body weight and there is no study comparing intrathecal morphine dose in thoracic surgery patients.
| Study group | Role | What they receive |
|---|---|---|
| 10 mcg/kg intrathecal morphine | Active comparator | For postoperative analgesia, before surgical incision, 10 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. Receives: Drug: Morphine |
| 7 mcg/kg intrathecal morphine | Active comparator | For postoperative analgesia, before surgical incision 7 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain)
Measured: Change from baseline pain scores at 24 hours
morphine consumption
At the end of surgery, patients were allowed to use the patient controlled analgesia (PCA) device. The PCA delivered bolus doses of morphine (0.02 mg/kg) every 10 minutes without a backround infusion. Morphine consumption (mg) was evaluated and recorded postoperative 24 hours.
Measured: Change from baseline morphine consumption at 24 hours
Secondary outcomes (5)
systolic arterial blood pressure
Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery.
Measured: change from baseline systolic blood pressure at 150 minutes
diastolic arterial blood pressure
Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery.
Measured: change from baseline diastolic blood pressure at 150 minutes
mean arterial blood pressure
Intraoperative mean arterial blood pressure (mmHg) values were recorded during surgery.
Measured: change from baseline mean arterial blood pressure at 150 minutes
heart rate
Intraoperative heart rate (beats/minute) values were recorded during surgery.
Measured: change from baseline heart rate at 150 minutes
side effects
All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start25 Apr 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588336
- Sponsor's protocol ID
- ITM1
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection
- ClinicalTrials.gov ID
- NCT05588336
- Acronym / sponsor ID
- ITM1
- Conditions
- Postoperative Pain
- Keywords
- postoperative analgesia, pain score, side effect, morphine, intrathecal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 20 Oct 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.
Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight.
Detailed description
Patients who underwent video-assisted thoracic surgery were divided into two groups: 10 mcg/kg and 7 mcg/kg intrathecal morphine for postoperative analgesia. Intraoperative and postoperative hemodynamic variables, postoperative morphine consumption, postoperative pain scores, side effects and additional analgesic requiretment were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mcg/kg intrathecal morphine | Active comparator | Drug: MorphineFor postoperative analgesia, before surgical incision, 10 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. |
| 7 mcg/kg intrathecal morphine | Active comparator | Drug: MorphineFor postoperative analgesia, before surgical incision 7 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- ASA class I and II
- Video-assisted thoracoscopic surgery
Key exclusion criteria (7 listed)
- < 18 years old
- ASA class > II
- Serious hepatic, cardiac, renal, metabolic, endocrine diseases
- Coagulation disfunction
- Allergy to any of the study drugs
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 |
|---|---|---|
| MorphineIn the literature, intrathecal morphine doses were applied according to the patients' actual body weight and there is no study comparing intrathecal morphine dose in thoracic surgery patients. | Drug | 10 mcg/kg intrathecal morphine, 7 mcg/kg intrathecal morphine |
Primary outcome
pain scores
Time frame: Change from baseline pain scores at 24 hours
Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain)
morphine consumption
Time frame: Change from baseline morphine consumption at 24 hours
At the end of surgery, patients were allowed to use the patient controlled analgesia (PCA) device. The PCA delivered bolus doses of morphine (0.02 mg/kg) every 10 minutes without a backround infusion. Morphine consumption (mg) was evaluated and recorded postoperative 24 hours.
5 secondary outcomes
systolic arterial blood pressure
Time frame: change from baseline systolic blood pressure at 150 minutes
diastolic arterial blood pressure
Time frame: change from baseline diastolic blood pressure at 150 minutes
mean arterial blood pressure
Time frame: change from baseline mean arterial blood pressure at 150 minutes
heart rate
Time frame: change from baseline heart rate at 150 minutes
side effects
Time frame: postoperative 24 hours
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 20 Oct 2022.
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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 Phase 4 study testing Morphine in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 20 Oct 2022. 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 Turkey (Türkiye). 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 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 scores (time frame: Change from baseline pain scores at 24 hours). 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 20 Oct 2022.