Intrathecal Morphine for Thoracoscopic Surgery

NCT ID: NCT05588336

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-10-10

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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mediha turktan

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ITM1

Identifier Type: -

Identifier Source: org_study_id

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