Intrathecal Morphine and Opioid Consumption After Thoracotomy

NCT07790250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Thoracotomy Analgesia
  • Intrathecal Morphine
  • Quality of Recovery (QoR-15)
  • Opioid Consumption, Postoperative
  • Postoperative Pain After Thoracic Surgery

Interventions

OTHER

İntercostal 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.

OTHER

Intrathecal 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 & Collaborators

  • Bursa City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-12-31
Completion
2021-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790250 on ClinicalTrials.gov