Intrathecal Morphine for Thoracoscopic Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Morphine

• Registration Number: NCT05588336
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study Start: 2022-04-25
• Status Verified: 2022-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 mcg/kg intrathecal morphine	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.
10 mcg/kg intrathecal morphine	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.

Primary Outcome Measures

Name	Time	Method
pain scores	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey