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CompletedNCT05855798Updated Sep 19, 2024

Ketamine and Magnesium in Erector Spinae Plane Block

A Phase 4 interventional study of Bupivacain and Magnesium sulfate in Postoperative Analgesia, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Cukurova University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.

Read the detailed description

Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.

For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.

After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.

02

Conditions studied

  • Postoperative Analgesia

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Keywords

  • erector spinae plane block
  • magnesium sulphate
  • ketamine HCl
  • bupivacaine
  • analgesia
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

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Lead sponsor

Cukurova University is the lead sponsor of 257 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • lung resection with video-assisted thoracoscopy,
  • voluntarily agree to participate in the study,
  • over 18 years old,
  • ASA I-III

Exclusion criteria

Exclusion Criteria:

  • ASA>III
  • Coagulation disorders or anticoagulant agent therapy,
  • Allergy or hypersensitivity to any drug to be will be used in the study,
  • Epilepsy,
  • High intracranial pressure,
  • Unwillingness to participate in the study
  • Inability to use the PCA device
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    control group

    Erector spinae plane block with 20 mL 0.5% bupivacaine

    Drug: Bupivacain

  • Active comparator
    magnesium group

    Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate

    Drug: Bupivacain · Drug: Magnesium sulfate

  • Active comparator
    ketamine group

    Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine

    Drug: Bupivacain · Drug: Ketamine Hydrochloride

Interventions

  • Bupivacaine is a local anesthetic agent commonly used in ESP block.

  • Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..

  • Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.

06

What researchers measure

Primary outcomes

  1. pain scores

    postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)

    Time frame: Change from baseline pain scores at 24 hours

  2. morphine consumption

    At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion.

    Time frame: Change from baseline morphine consumption at 24 hours

Secondary outcomes

  1. side effects

    All of patients will visited in the thoracic surgery ward after surgery and side effects (if occured) will recorded.

    Time frame: postoperative 24 hours

07

Study locations

1 site
  • Cukurova University
    Adana, Adana 01330, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05855798
Responsible party
mediha turktan (associate professor, Cukurova University) — Principal investigator
First posted
May 11, 2023
Start date
May 10, 2023
Primary completion
Oct 2, 2023
Completion
Oct 2, 2023
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Magnesium Sulfate · Ketamine

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