Thoracotomy Analgesia, Intrathecal Morphine, Quality of Recovery (QoR-15), Opioid Consumption, Postoperative, Postoperative Pain After Thoracic Surgery
Conditions
Keywords
thoracotomy analgesia, intrathecal morphine, Quality of Recovery-15, opioid consumption
Brief 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 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.
Interventions
OTHERİntercostal nerve block
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.
OTHERIntrathecal Morphine
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.
Sponsors
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Flow at 25-75% of FVC From Baseline to Postoperative Assessment | 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 to First Postoperative Rescue Analgesic Requirement | 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 to First Postoperative Mobilisation | 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. |
| Incidence of Opioid-Related Adverse Effects | 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. |
| Postoperative Pain Intensity at Rest | 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 |
| Postoperative Pain Intensity During Coughing | 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. |
| Quality of Recovery at 24 Hours After Surgery | 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. |
| Change in Forced Vital Capacity (FVC) From Baseline to Postoperative Assessment | 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. |
| Change in Forced Expiratory Volume in One Second (FEV1) From Baseline to Postoperative Assessment | 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. |
| Change in Peak Expiratory Flow From Baseline to Postoperative Assessment | 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. |
| Change in FEV1/FVC Ratio From Baseline to Postoperative Assessment | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed