NCT05588336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 12, 2022

Last Update Submit

October 18, 2022

Conditions

Postoperative Pain

Keywords

postoperative analgesiapain scoreside effectmorphineintrathecal

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • systolic arterial blood pressure

    change from baseline systolic blood pressure at 150 minutes

  • diastolic arterial blood pressure

    change from baseline diastolic blood pressure at 150 minutes

  • mean arterial blood pressure

    change from baseline mean arterial blood pressure at 150 minutes

  • heart rate

    change from baseline heart rate at 150 minutes

  • side effects

    postoperative 24 hours

Study Arms (2)

10 mcg/kg intrathecal morphine

ACTIVE COMPARATOR

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

7 mcg/kg intrathecal morphine

ACTIVE COMPARATOR

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

Interventions

MorphineDRUG

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.

10 mcg/kg intrathecal morphine7 mcg/kg intrathecal morphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • ASA class I and II
  • Video-assisted thoracoscopic surgery

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 20, 2022

Study Start

April 25, 2022

Primary Completion

October 10, 2022

Study Completion

October 10, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

TU(1)