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NCT Number: NCT07790250

Intrathecal Morphine and Opioid Consumption After Thoracotomy

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, nilüfer, 16010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

İntercostal nerve block

Other

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Intensity at Rest

    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

  2. Postoperative Pain Intensity During Coughing

    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.

  3. Quality of Recovery at 24 Hours After Surgery

    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.

  4. Change in Forced Vital Capacity (FVC) From Baseline to Postoperative Assessment

    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.

  5. Change in Forced Expiratory Volume in One Second (FEV1) From Baseline to Postoperative Assessment

    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.

  6. Change in FEV1/FVC Ratio From Baseline to Postoperative Assessment

    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.

  7. Change in Peak Expiratory Flow From Baseline to Postoperative Assessment

    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.

  8. Change in Forced Expiratory Flow at 25-75% of FVC From Baseline to Postoperative Assessment

    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.

  9. Time to First Postoperative Rescue Analgesic Requirement

    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.

  10. Time to First Postoperative Mobilisation

    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.

  11. Incidence of Opioid-Related Adverse Effects

    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.

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

Effect of Intrathecal Morphine on Opioid Consumption and Quality of Recovery After Thoracotomy: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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