Intrathecal Morphine for Thoracoscopic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 mcg/kg intrathecal morphine<br>For postoperative analgesia, before surgical incision, 10 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. | Drug: Morphine<br>* 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.<br>|
| Active Comparator: 7 mcg/kg intrathecal morphine<br>For postoperative analgesia, before surgical incision 7 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position. | Drug: Morphine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain) | Change from baseline pain scores at 24 hours | 
| morphine consumption | 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. | Change from baseline morphine consumption at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic arterial blood pressure | Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery. | change from baseline systolic blood pressure at 150 minutes | 
| diastolic arterial blood pressure | Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery. | change from baseline diastolic blood pressure at 150 minutes | 
| mean arterial blood pressure | Intraoperative mean arterial blood pressure (mmHg) values were recorded during surgery. | change from baseline mean arterial blood pressure at 150 minutes | 
| heart rate | Intraoperative heart rate (beats/minute) values were recorded during surgery. | change from baseline heart rate at 150 minutes | 
| side effects | All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded. | postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, pain score, side effect, morphine, intrathecal