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Intrathecal Morphine for Thoracoscopic Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Morphine
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative analgesia, pain score, side effect, morphine, intrathecal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10 mcg/kg intrathecal morphine

7 mcg/kg intrathecal morphine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

systolic arterial blood pressure
Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery.
diastolic arterial blood pressure
Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery.
mean arterial blood pressure
Intraoperative mean arterial blood pressure (mmHg) values were recorded during surgery.
heart rate
Intraoperative heart rate (beats/minute) values were recorded during surgery.
side effects
All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded.

Full Information

First Posted
October 12, 2022
Last Updated
October 18, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05588336
Brief Title
Intrathecal Morphine for Thoracoscopic Surgery
Official Title
Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative analgesia, pain score, side effect, morphine, intrathecal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mcg/kg intrathecal morphine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
7 mcg/kg intrathecal morphine
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Morphine
Intervention Description
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 Outcome Measure Information:
Title
pain scores
Description
Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain)
Time Frame
Change from baseline pain scores at 24 hours
Title
morphine consumption
Description
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.
Time Frame
Change from baseline morphine consumption at 24 hours
Secondary Outcome Measure Information:
Title
systolic arterial blood pressure
Description
Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery.
Time Frame
change from baseline systolic blood pressure at 150 minutes
Title
diastolic arterial blood pressure
Description
Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery.
Time Frame
change from baseline diastolic blood pressure at 150 minutes
Title
mean arterial blood pressure
Description
Intraoperative mean arterial blood pressure (mmHg) values were recorded during surgery.
Time Frame
change from baseline mean arterial blood pressure at 150 minutes
Title
heart rate
Description
Intraoperative heart rate (beats/minute) values were recorded during surgery.
Time Frame
change from baseline heart rate at 150 minutes
Title
side effects
Description
All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded.
Time Frame
postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01130
Country
Turkey

12. IPD Sharing Statement

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Intrathecal Morphine for Thoracoscopic Surgery

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