Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05851768

Collaborator

(none)

Enrollment

Arms

5.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Bupivacaine Drug: Bupivacaine + Magnesium Drug: Bupivacaine + Dexmedetomidine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

Double blinded

Primary Purpose:

Treatment

Official Title:

Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain

Anticipated Study Start Date :

May 14, 2023

Anticipated Primary Completion Date :

Oct 10, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erector spinae plane block with 0.25% bupivacaine Patients will receive ultrasound guided ESPB with 0.25% bupivacaine	Drug: Bupivacaine Bupivacaine 0.25%
Experimental: Erector spinae plane block with 0.25% bupivacaine and Magnesium Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium	Drug: Bupivacaine + Magnesium Bupivacaine 0.25% + Magnesium
Experimental: Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine	Drug: Bupivacaine + Dexmedetomidine Bupivacaine 0.25% + Dexmedetomidine

Arm

Intervention/Treatment

Active Comparator: Erector spinae plane block with 0.25% bupivacaine

Patients will receive ultrasound guided ESPB with 0.25% bupivacaine

Drug: Bupivacaine

Bupivacaine 0.25%

Experimental: Erector spinae plane block with 0.25% bupivacaine and Magnesium

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

Drug: Bupivacaine + Magnesium

Bupivacaine 0.25% + Magnesium

Experimental: Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine

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

Drug: Bupivacaine + Dexmedetomidine

Bupivacaine 0.25% + Dexmedetomidine

Outcome Measures

Primary Outcome Measures

Total postoperative morphine consumption [First 24 hours postoperatively]
Total dose of morphine needed postoperatively in the first 24 h

Secondary Outcome Measures

Time to first postoperative rescue analgesia. [First 24 hours postoperatively]
Time to first postoperative rescue analgesia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

Principal Investigator: Walaa Y Elsabeeny, MD, Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
Study Director: Ahmed A Mohamed, MD, Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walaa Youssef Elsabeeny, Assistant professor of Anesthesia and Pain management, National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT05851768

Other Study ID Numbers:

N-80-2022/NSC

First Posted:

May 10, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dexmedetomidine

Bupivacaine

Study Results

No Results Posted as of May 10, 2023