Intrathecal Morphine and Opioid Consumption After Thoracotomy

NCT07790250 | Completed

• 2 other identifiers: 2019-6/282011-KAEK-26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery to 24 hours postoperatively

Secondary Outcomes (11)

• Postoperative Pain Intensity at Rest

  At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively

• Postoperative Pain Intensity During Coughing

  At 0, 1, 2, 4, 6, 12, and 24 hours postoperatively

• Quality of Recovery at 24 Hours After Surgery

  24 hours postoperatively

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

  Preoperatively and 24 hours postoperatively

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

  Preoperatively and 24 hours postoperatively

Study Arms (2)

intrathecal morphine group

EXPERIMENTAL

Other: İntercostal nerve block; Other: Intrathecal Morphine

control group

ACTIVE COMPARATOR

Other: İntercostal nerve block

Interventions

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.

control group; intrathecal morphine group

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.

intrathecal morphine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, nilüfer, 16010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 27, 2026
• Study Start: April 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: August 27, 2026

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)