Bursa City Hospital
Bursa, nilüfer, 16010, Turkey (Türkiye)
NCT Number: NCT07790250
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bursa, nilüfer, 16010, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Time frame: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
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
Time frame: At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
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.
Time frame: Preoperatively and 24 hours postoperatively
Forced vital capacity (FVC), measured by spirometry before surgery and after surgery. The change from the preoperative baseline value will be evaluated.
Time frame: Preoperatively and 24 hours postoperatively
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.
Time frame: Preoperatively and 24 hours postoperatively
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), measured by spirometry before surgery and after surgery.
Time frame: Preoperatively and 24 hours postoperatively
Peak expiratory flow (PEF), measured by spirometry before surgery and after surgery. The change from the preoperative baseline value will be evaluated.
Time frame: Preoperatively and 24 hours postoperatively
Forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), measured by spirometry before surgery and after surgery.
Time frame: From the end of surgery to 24 hours postoperatively
Time from the end of surgery to the first administration of rescue analgesic medication for postoperative pain.
Time frame: From the end of surgery to 24 hours postoperatively
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.
Time frame: From the end of surgery to 24 hours postoperatively
Incidence of opioid-related adverse effects, including nausea, vomiting, pruritus, sedation, respiratory depression, and urinary retention during the postoperative period.
Bursa City Hospital
Other Gov
Effect of Intrathecal Morphine on Opioid Consumption and Quality of Recovery After Thoracotomy: A Randomized Controlled Trial
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