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Completed

NCT Number: NCT05588336

Intrathecal Morphine for Thoracoscopic Surgery

Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University

Adana, 01130, Turkey (Türkiye)

About this study

Patients who underwent video-assisted thoracic surgery were divided into two groups: 10 mcg/kg and 7 mcg/kg intrathecal morphine for postoperative analgesia. Intraoperative and postoperative hemodynamic variables, postoperative morphine consumption, postoperative pain scores, side effects and additional analgesic requiretment were recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • > 18 years old
  • ASA class I and II
  • Video-assisted thoracoscopic surgery

Exclusion criteria

  • < 18 years old
  • ASA class > II
  • Serious hepatic, cardiac, renal, metabolic, endocrine diseases
  • Coagulation disfunction
  • Allergy to any of the study drugs
  • Pneumonectomy
  • Infection in the lumbar region

Treatment and study plan

Morphine

Drug

In the literature, intrathecal morphine doses were applied according to the patients' actual body weight and there is no study comparing intrathecal morphine dose in thoracic surgery patients.

Primary outcomes

  1. pain scores

    Time frame: Change from baseline pain scores at 24 hours

    Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain)

  2. morphine consumption

    Time frame: Change from baseline morphine consumption at 24 hours

    At the end of surgery, patients were allowed to use the patient controlled analgesia (PCA) device. The PCA delivered bolus doses of morphine (0.02 mg/kg) every 10 minutes without a backround infusion. Morphine consumption (mg) was evaluated and recorded postoperative 24 hours.

Secondary outcomes

  1. systolic arterial blood pressure

    Time frame: change from baseline systolic blood pressure at 150 minutes

    Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery.

  2. diastolic arterial blood pressure

    Time frame: change from baseline diastolic blood pressure at 150 minutes

    Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery.

  3. mean arterial blood pressure

    Time frame: change from baseline mean arterial blood pressure at 150 minutes

    Intraoperative mean arterial blood pressure (mmHg) values were recorded during surgery.

  4. heart rate

    Time frame: change from baseline heart rate at 150 minutes

    Intraoperative heart rate (beats/minute) values were recorded during surgery.

  5. side effects

    Time frame: postoperative 24 hours

    All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2022
Registry last updated
Oct 20, 2022

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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