NCT05851768

Brief Summary

Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
May 2023Dec 2026

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2026

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

May 1, 2023

Last Update Submit

June 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total postoperative morphine consumption

    Total dose of morphine needed postoperatively in the first 24 h

    First 24 hours postoperatively

Secondary Outcomes (1)

  • Time to first postoperative rescue analgesia.

    First 24 hours postoperatively

Study Arms (3)

Erector spinae plane block with 0.25% bupivacaine

ACTIVE COMPARATOR

Patients will receive ultrasound guided ESPB with 0.25% bupivacaine

Drug: Bupivacaine

Erector spinae plane block with 0.25% bupivacaine and Magnesium

EXPERIMENTAL

Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium

Drug: Bupivacaine + Magnesium

Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine

EXPERIMENTAL

Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine

Drug: Bupivacaine + Dexmedetomidine

Interventions

Bupivacaine 0.25% + Dexmedetomidine

Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine

Bupivacaine 0.25%

Erector spinae plane block with 0.25% bupivacaine

Bupivacaine 0.25% + Magnesium

Erector spinae plane block with 0.25% bupivacaine and Magnesium

Eligibility Criteria

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

You may qualify if:

  • Age from 18 to 65 years.
  • Male and female sexes.
  • ASA I-II.,III
  • Cancer patients undergoing thoracotomy incisions
  • Body mass index (BMI) from 18.5 to 30 kg/m2

You may not qualify if:

  • Patient refusal
  • Known allergy to any of the used drugs
  • Low platelet count, any coagulation defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

BupivacaineMagnesiumDexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Walaa Y Elsabeeny, MD

    Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR
  • Ahmed A Mohamed, MD

    Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Walaa Y Elsabeeny, MD

CONTACT

Ahmed A Mohamed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Pain management

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

December 27, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations