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Clinical Trials/NCT05588336
NCT05588336
Completed
Phase 4

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

Cukurova University1 site in 1 country46 target enrollmentApril 25, 2022
InterventionsMorphine

Overview

Phase
Phase 4
Intervention
Morphine
Conditions
Postoperative Pain
Sponsor
Cukurova University
Enrollment
46
Locations
1
Primary Endpoint
pain scores
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2022
End Date
October 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mediha turktan

associate professor

Cukurova University

Eligibility Criteria

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

Arms & Interventions

7 mcg/kg intrathecal morphine

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.

Intervention: Morphine

10 mcg/kg intrathecal morphine

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.

Intervention: Morphine

Outcomes

Primary Outcomes

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)

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

  • systolic arterial blood pressure(change from baseline systolic blood pressure at 150 minutes)
  • diastolic arterial blood pressure(change from baseline diastolic blood pressure at 150 minutes)
  • mean arterial blood pressure(change from baseline mean arterial blood pressure at 150 minutes)
  • heart rate(change from baseline heart rate at 150 minutes)
  • side effects(postoperative 24 hours)

Study Sites (1)

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