Thoracotomy AnalgesiaNCT07790250
Intrathecal Morphine and Opioid Consumption After Thoracotomy
A study testing İntercostal nerve block and Intrathecal Morphine in people with Thoracotomy Analgesia and Intrathecal Morphine, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy is associated with some of the most severe postoperative pain of any surgical procedure. Inadequate analgesia restricts inspiratory effort and impairs the ability to cough, predisposing patients to atelectasis, retained secretions and pneumonia, delaying mobilisation, and contributing to the development of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracotomy Analgesia, Intrathecal Morphine, Quality of Recovery (QoR-15)
- What is being tested?
- İntercostal nerve block and Intrathecal Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients scheduled for elective open thoracotomy under general anesthesia.
- Patients undergoing thoracotomy through a standard posterolateral or anterolateral thoracotomy incision.
- Patients eligible to receive surgeon-performed intercostal nerve blockade as part of the standard postoperative analgesic protocol.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to understand the study procedures and comply with the study assessments.
- Provision of written informed consent before enrollment.
Who cannot join
- Age <18 years.
- Emergency or urgent thoracic surgery.
- Video-assisted thoracoscopic surgery (VATS), robotic-assisted thoracic surgery, or other minimally invasive procedures without an open thoracotomy.
- Previous thoracic surgery on the operative side that may significantly alter thoracic wall innervation.
- Contraindication to neuraxial anesthesia or intrathecal morphine, including:
- Coagulopathy or clinically significant bleeding disorder.
Show all 21Show fewer
- Therapeutic anticoagulation precluding neuraxial procedures.
- Local infection at the intended puncture site or systemic infection.
- Known hypersensitivity to morphine or other study medications.
- Severe spinal anatomical abnormalities preventing safe intrathecal access.
- Increased intracranial pressure or other contraindications to spinal anesthesia.
- Chronic opioid use or long-term opioid therapy before surgery.
- Pre-existing chronic pain requiring regular analgesic medication.
- Severe pre-existing pulmonary disease that would substantially interfere with postoperative pulmonary function assessment.
- Pre-existing neurological or neuromuscular disease that could affect respiratory function, pain assessment, or mobilization.
- Severe hepatic or renal dysfunction that could significantly affect opioid metabolism or elimination.
- Pregnancy or breastfeeding.
- Inability to communicate adequately or reliably report pain or complete the Quality of Recovery-15 (QoR-15) questionnaire.
- Inability to perform reliable preoperative or postoperative pulmonary function testing.
- Any condition judged by the investigator to make participation unsafe or to interfere substantially with study outcomes.
- Refusal to participate or withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intrathecal Morphine on Opioid Consumption and Quality of Recovery After Thoracotomy: A Randomized Controlled Trial
Thoracotomy is associated with some of the most severe postoperative pain of any surgical procedure. Inadequate analgesia restricts inspiratory effort and impairs the ability to cough, predisposing patients to atelectasis, retained secretions and pneumonia, delaying mobilisation, and contributing to the development of chronic post-thoracotomy pain.
Intercostal nerve blockade, performed by the surgeon under direct vision before chest closure, is a widely used and technically reliable component of analgesia after thoracotomy. Its effect is nevertheless limited by the duration of action of the local anaesthetic, so that analgesic coverage may become inadequate during the remainder of the first postoperative day, when opioid requirements are typically highest. Thoracic epidural analgesia provides more prolonged coverage but is constrained by technical failure, catheter displacement, haemodynamic effects and contraindications related to anticoagulation.
Read more
Intrathecal morphine represents an alternative means of extending analgesia. It is a single-shot technique that is technically straightforward, carries a low failure rate, requires no indwelling catheter, and produces neither motor nor sensory blockade, thereby permitting early mobilisation. Whether adding intrathecal morphine to an intercostal block confers additional benefit in open thoracotomy has not been established: existing thoracotomy trials are small, more recent data derive predominantly from video-assisted thoracoscopic surgery, quality of recovery has not been assessed with a validated patient-reported instrument, and postoperative pulmonary function has been characterised only by single bedside flow measurements rather than comprehensive spirometry.
In this randomised controlled trial, all adults undergoing elective thoracotomy receive an intercostal nerve block together with standard multimodal analgesia. Patients are randomly allocated to receive, in addition, a single dose of intrathecal morphine or no intrathecal injection.
The primary outcome is total opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes comprise pain intensity at rest and on coughing, assessed with a visual analogue scale at seven time points over 24 hours; quality of recovery, assessed with the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours; preoperative and postoperative pulmonary function (FVC, FEV1, FEV1/FVC, PEF and FEF25-75); time to first analgesic requirement; time to first mobilisation; and the incidence of opioid-related adverse effects.
Read the detailed description
Thoracotomy is associated with some of the most severe postoperative pain of any surgical procedure. Inadequate analgesia restricts inspiratory effort and impairs the ability to cough, predisposing patients to atelectasis, retained secretions and pneumonia, delaying mobilisation, and contributing to the development of chronic post-thoracotomy pain.
Intercostal nerve blockade, performed by the surgeon under direct vision before chest closure, is a widely used and technically reliable component of analgesia after thoracotomy. Its effect is nevertheless limited by the duration of action of the local anaesthetic, so that analgesic coverage may become inadequate during the remainder of the first postoperative day, when opioid requirements are typically highest. Thoracic epidural analgesia provides more prolonged coverage but is constrained by technical failure, catheter displacement, haemodynamic effects and contraindications related to anticoagulation.
Intrathecal morphine represents an alternative means of extending analgesia. It is a single-shot technique that is technically straightforward, carries a low failure rate, requires no indwelling catheter, and produces neither motor nor sensory blockade, thereby permitting early mobilisation. Whether adding intrathecal morphine to an intercostal block confers additional benefit in open thoracotomy has not been established: existing thoracotomy trials are small, more recent data derive predominantly from video-assisted thoracoscopic surgery, quality of recovery has not been assessed with a validated patient-reported instrument, and postoperative pulmonary function has been characterised only by single bedside flow measurements rather than comprehensive spirometry.
In this randomised controlled trial, all adults undergoing elective thoracotomy receive an intercostal nerve block together with standard multimodal analgesia. Patients are randomly allocated to receive, in addition, a single dose of intrathecal morphine or no intrathecal injection.
The primary outcome is total opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes comprise pain intensity at rest and on coughing, assessed with a visual analogue scale at seven time points over 24 hours; quality of recovery, assessed with the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours; preoperative and postoperative pulmonary function (FVC, FEV1, FEV1/FVC, PEF and FEF25-75); time to first analgesic requirement; time to first mobilisation; and the incidence of opioid-related adverse effects.
- Conditions
- Thoracotomy Analgesia, Intrathecal Morphine, Quality of Recovery (QoR-15), Opioid Consumption, Postoperative, Postoperative Pain After Thoracic Surgery
- Being tested
- İntercostal nerve block, Intrathecal Morphine
- Keywords
- thoracotomy analgesia, intrathecal morphine, Quality of Recovery-15, opioid consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntercostal nerve blockOther
Surgical intercostal nerve blockade was performed by the surgeon under direct vision before chest closure. The intercostal nerves were identified within the neurovascular bundle along the inferior border of the ribs, and a predetermined volume of local anaesthetic was injected at the relevant intercostal spaces.
Intrathecal MorphineOther
Intrathecal morphine was administered as a single preoperative dose into the lumbar intrathecal space under aseptic conditions. Following confirmation of free cerebrospinal fluid flow, the predetermined dose of preservative-free morphine was injected intrathecally. No intrathecal catheter was inserted.
| Study group | Role | What they receive |
|---|---|---|
| intrathecal morphine group | Experimental | Not described Receives: Other: İntercostal nerve block; Other: Intrathecal Morphine |
| control group | Active comparator | Not described Receives: Other: İntercostal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total opioid consumption during the first 24 postoperative hours, calculated as intravenous morphine equivalents (mg). Opioids administered as part of postoperative analgesic management will be converted to intravenous morphine equivalents using standard equianalgesic conversion ratios.
Measured: From the end of surgery to 24 hours postoperatively
Secondary outcomes (11)
Postoperative Pain Intensity at Rest
Pain intensity at rest assessed using a visual analogue scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable
Measured: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
Postoperative Pain Intensity During Coughing
Pain intensity during coughing assessed using a visual analogue scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
Quality of Recovery at 24 Hours After Surgery
Quality of recovery assessed using the Quality of Recovery-40 (QoR-40) questionnaire. The QoR-40 consists of 40 items assessing five dimensions of postoperative recovery: physical comfort, emotional state, physical independence, psychological support, and pain. The total score ranges from 40 to 200, with higher scores indicating better quality of recovery.
Measured: 24 hours postoperatively
Change in Forced Vital Capacity (FVC) From Baseline to Postoperative Assessment
Forced vital capacity (FVC), measured by spirometry before surgery and after surgery. The change from the preoperative baseline value will be evaluated.
Measured: Preoperatively and 24 hours postoperatively
Change in Forced Expiratory Volume in One Second (FEV1) From Baseline to Postoperative Assessment
Forced expiratory volume in one second (FEV1), measured by spirometry before surgery and after surgery. The change from the preoperative baseline value will be evaluated.
Measured: Preoperatively and 24 hours postoperatively
Change in FEV1/FVC Ratio From Baseline to Postoperative Assessment
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), measured by spirometry before surgery and after surgery.
Measured: Preoperatively and 24 hours postoperatively
Change in Peak Expiratory Flow From Baseline to Postoperative Assessment
Peak expiratory flow (PEF), measured by spirometry before surgery and after surgery. The change from the preoperative baseline value will be evaluated.
Measured: Preoperatively and 24 hours postoperatively
Change in Forced Expiratory Flow at 25-75% of FVC From Baseline to Postoperative Assessment
Forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), measured by spirometry before surgery and after surgery.
Measured: Preoperatively and 24 hours postoperatively
Time to First Postoperative Rescue Analgesic Requirement
Time from the end of surgery to the first administration of rescue analgesic medication for postoperative pain.
Measured: From the end of surgery to 24 hours postoperatively
Time to First Postoperative Mobilisation
Time from the end of surgery to the first mobilisation, defined as the first time the patient is assisted to stand and/or walk after surgery.
Measured: From the end of surgery to 24 hours postoperatively
Incidence of Opioid-Related Adverse Effects
Incidence of opioid-related adverse effects, including nausea, vomiting, pruritus, sedation, respiratory depression, and urinary retention during the postoperative period.
Measured: From the end of surgery to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracotomy AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790250
- Sponsor's protocol ID
- 2019-6/28
- Other IDs
- 2011-KAEK-26
- Status last verified
- Mar 2019
- First submitted
- 19 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
Askar FZ, Kocabas S, Yucel S, Samancilar O, Cetin HY, Uyar M. The efficacy of intrathecal morphine in post-thoracotomy pain management. J Int Med Res. 2007;35(3):314-322. - Earlier thoracotomy trial showing reduced opioid use and better peak expiratory flow with intrathecal morphine. Vijitpavan A, Kittikunakorn N, Komonhirun R. Comparison between intrathecal morphine and intravenous patient control analgesia for pain control after video-assisted thoracoscopic surgery: a pilot randomized controlled study. PLoS One. 2022;17(4):e0266324. - Recent thoracic surgery trial; supports the rationale and shows the effect is concentrated in the first 24 hours. Laigaard J, Pedersen C, Rønsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021;126(5):1029-1037. - Basis for what size of reduction in opioid use counts as clinically meaningful.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Morphine on Opioid Consumption and Quality of Recovery After Thoracotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07790250
- Acronym / sponsor ID
- 2019-6/28
- Conditions
- Thoracotomy Analgesia, Intrathecal Morphine, Quality of Recovery (QoR-15), Opioid Consumption, Postoperative, Postoperative Pain After Thoracic Surgery
- Keywords
- thoracotomy analgesia, intrathecal morphine, Quality of Recovery-15, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 27 Aug 2026 (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.
Thoracotomy is associated with some of the most severe postoperative pain of any surgical procedure. Inadequate analgesia restricts inspiratory effort and impairs the ability to cough, predisposing patients to atelectasis, retained secretions and pneumonia, delaying mobilisation, and contributing to the development of chronic post-thoracotomy pain.
Intercostal nerve blockade, performed by the surgeon under direct vision before chest closure, is a widely used and technically reliable component of analgesia after thoracotomy. Its effect is nevertheless limited by the duration of action of the local anaesthetic, so that analgesic coverage may become inadequate during the remainder of the first postoperative day, when opioid requirements are typically highest. Thoracic epidural analgesia provides more prolonged coverage but is constrained by technical failure, catheter displacement, haemodynamic effects and contraindications related to anticoagulation.
Intrathecal morphine represents an alternative means of extending analgesia. It is a single-shot technique that is technically straightforward, carries a low failure rate, requires no indwelling catheter, and produces neither motor nor sensory blockade, thereby permitting early mobilisation. Whether adding intrathecal morphine to an intercostal block confers additional benefit in open thoracotomy has not been established: existing thoracotomy trials are small, more recent data derive predominantly from video-assisted thoracoscopic surgery, quality of recovery has not been assessed with a validated patient-reported instrument, and postoperative pulmonary function has been characterised only by single bedside flow measurements rather than comprehensive spirometry.
In this randomised controlled trial, all adults undergoing elective thoracotomy receive an intercostal nerve block together with standard multimodal analgesia. Patients are randomly allocated to receive, in addition, a single dose of intrathecal morphine or no intrathecal injection.
The primary outcome is total opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes comprise pain intensity at rest and on coughing, assessed with a visual analogue scale at seven time points over 24 hours; quality of recovery, assessed with the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours; preoperative and postoperative pulmonary function (FVC, FEV1, FEV1/FVC, PEF and FEF25-75); time to first analgesic requirement; time to first mobilisation; and the incidence of opioid-related adverse effects.
Detailed description
Thoracotomy is associated with some of the most severe postoperative pain of any surgical procedure. Inadequate analgesia restricts inspiratory effort and impairs the ability to cough, predisposing patients to atelectasis, retained secretions and pneumonia, delaying mobilisation, and contributing to the development of chronic post-thoracotomy pain.
Intercostal nerve blockade, performed by the surgeon under direct vision before chest closure, is a widely used and technically reliable component of analgesia after thoracotomy. Its effect is nevertheless limited by the duration of action of the local anaesthetic, so that analgesic coverage may become inadequate during the remainder of the first postoperative day, when opioid requirements are typically highest. Thoracic epidural analgesia provides more prolonged coverage but is constrained by technical failure, catheter displacement, haemodynamic effects and contraindications related to anticoagulation.
Intrathecal morphine represents an alternative means of extending analgesia. It is a single-shot technique that is technically straightforward, carries a low failure rate, requires no indwelling catheter, and produces neither motor nor sensory blockade, thereby permitting early mobilisation. Whether adding intrathecal morphine to an intercostal block confers additional benefit in open thoracotomy has not been established: existing thoracotomy trials are small, more recent data derive predominantly from video-assisted thoracoscopic surgery, quality of recovery has not been assessed with a validated patient-reported instrument, and postoperative pulmonary function has been characterised only by single bedside flow measurements rather than comprehensive spirometry.
In this randomised controlled trial, all adults undergoing elective thoracotomy receive an intercostal nerve block together with standard multimodal analgesia. Patients are randomly allocated to receive, in addition, a single dose of intrathecal morphine or no intrathecal injection.
The primary outcome is total opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes comprise pain intensity at rest and on coughing, assessed with a visual analogue scale at seven time points over 24 hours; quality of recovery, assessed with the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours; preoperative and postoperative pulmonary function (FVC, FEV1, FEV1/FVC, PEF and FEF25-75); time to first analgesic requirement; time to first mobilisation; and the incidence of opioid-related adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal morphine group | Experimental | Other: İntercostal nerve block, Other: Intrathecal Morphine |
| control group | Active comparator | Other: İntercostal nerve block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Patients scheduled for elective open thoracotomy under general anesthesia.
- Patients undergoing thoracotomy through a standard posterolateral or anterolateral thoracotomy incision.
- Patients eligible to receive surgeon-performed intercostal nerve blockade as part of the standard postoperative analgesic protocol.
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (21 listed)
- Age <18 years.
- Emergency or urgent thoracic surgery.
- Video-assisted thoracoscopic surgery (VATS), robotic-assisted thoracic surgery, or other minimally invasive procedures without an open thoracotomy.
- Previous thoracic surgery on the operative side that may significantly alter thoracic wall innervation.
- Contraindication to neuraxial anesthesia or intrathecal morphine, including:
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 |
|---|---|---|
| İntercostal nerve blockSurgical intercostal nerve blockade was performed by the surgeon under direct vision before chest closure. The intercostal nerves were identified within the neurovascular bundle along the inferior border of the ribs, and a predetermined volume of local anaesthetic was injected at the relevant intercostal spaces. | Other | control group, intrathecal morphine group |
| Intrathecal MorphineIntrathecal morphine was administered as a single preoperative dose into the lumbar intrathecal space under aseptic conditions. Following confirmation of free cerebrospinal fluid flow, the predetermined dose of preservative-free morphine was injected intrathecally. No intrathecal catheter was inserted. | Other | intrathecal morphine group |
Primary outcome
Opioid consumption
Time frame: From the end of surgery to 24 hours postoperatively
Total opioid consumption during the first 24 postoperative hours, calculated as intravenous morphine equivalents (mg). Opioids administered as part of postoperative analgesic management will be converted to intravenous morphine equivalents using standard equianalgesic conversion ratios.
11 secondary outcomes
Postoperative Pain Intensity at Rest
Time frame: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
Postoperative Pain Intensity During Coughing
Time frame: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
Quality of Recovery at 24 Hours After Surgery
Time frame: 24 hours postoperatively
Change in Forced Vital Capacity (FVC) From Baseline to Postoperative Assessment
Time frame: Preoperatively and 24 hours postoperatively
Change in Forced Expiratory Volume in One Second (FEV1) From Baseline to Postoperative Assessment
Time frame: Preoperatively and 24 hours postoperatively
Change in FEV1/FVC Ratio From Baseline to Postoperative Assessment
Time frame: Preoperatively and 24 hours postoperatively
Change in Peak Expiratory Flow From Baseline to Postoperative Assessment
Time frame: Preoperatively and 24 hours postoperatively
Change in Forced Expiratory Flow at 25-75% of FVC From Baseline to Postoperative Assessment
Time frame: Preoperatively and 24 hours postoperatively
Time to First Postoperative Rescue Analgesic Requirement
Time frame: From the end of surgery to 24 hours postoperatively
Time to First Postoperative Mobilisation
Time frame: From the end of surgery to 24 hours postoperatively
Incidence of Opioid-Related Adverse Effects
Time frame: From the end of surgery to 24 hours postoperatively
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 27 Aug 2026.
- BackgroundAskar FZ, Kocabas S, Yucel S, Samancilar O, Cetin HY, Uyar M. The efficacy of intrathecal morphine in post-thoracotomy pain management. J Int Med Res. 2007;35(3):314-322. - Earlier thoracotomy trial showing reduced opioid use and better peak expiratory flow with intrathecal morphine. Vijitpavan A, Kittikunakorn N, Komonhirun R. Comparison between intrathecal morphine and intravenous patient control analgesia for pain control after video-assisted thoracoscopic surgery: a pilot randomized controlled study. PLoS One. 2022;17(4):e0266324. - Recent thoracic surgery trial; supports the rationale and shows the effect is concentrated in the first 24 hours. Laigaard J, Pedersen C, Rønsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021;126(5):1029-1037. - Basis for what size of reduction in opioid use counts as clinically meaningful.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Analgesia
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 İntercostal nerve block and Intrathecal Morphine in people with Thoracotomy Analgesia and Intrathecal Morphine, run by Bursa City Hospital 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 7 inclusion and 21 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 27 Aug 2026. 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.
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?
Opioid consumption (time frame: From the end of surgery to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07790250, which also lists 1 linked publication.
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 27 Aug 2026.