Intrathecal Morphine for Thoracoscopic Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588336
• Other study ID #: ITM1
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2022
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Morphine
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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

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