Intrathecal Morphine for Thoracoscopic Surgery

• Sponsor: Cukurova University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05588336
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Morphine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection
• Actual Study Start Date: Apr 25, 2022
• Actual Primary Completion Date: Oct 10, 2022
• Actual Study Completion Date: Oct 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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

1. systolic arterial blood pressure [change from baseline systolic blood pressure at 150 minutes]

   Intraoperative systolic arterial blood pressure (mmHg) values were recorded during surgery.

2. diastolic arterial blood pressure [change from baseline diastolic blood pressure at 150 minutes]

   Intraoperative diastolic arterial blood pressure (mmHg) values were recorded during surgery.

3. 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.

4. heart rate [change from baseline heart rate at 150 minutes]

   Intraoperative heart rate (beats/minute) values were recorded during surgery.

5. side effects [postoperative 24 hours]

   All of patients were visited in the thoracic surgery ward after surgery and side effects were evaluated and recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana		Turkey	01130

Sponsors and Collaborators

• Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mediha turktan, associate professor, Cukurova University
• ClinicalTrials.gov Identifier: NCT05588336
• Other Study ID Numbers: ITM1
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by mediha turktan, associate professor, Cukurova University: postoperative analgesia; pain score; side effect; morphine; intrathecal
• Additional relevant MeSH terms: Pain, Postoperative; Morphine

Study Results

No Results Posted as of Oct 20, 2022