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Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery

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ClinicalTrials.gov Identifier: NCT04380168
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Amira Fathy Hefni,MD-EDIC, Ain Shams University

Brief Summary:
in our study we are trying to reach to the preferred adjuvant from either ketamine or dexmedetomidine to be added to bupivacaine local anesthetic during pec 11 modified block as regard its efficacy and duration of postoperative analgesia it can maintain after modified radical mastectomy surgery so as to achieve better control of postoperative pain than using local anesthetic alone.

Condition or disease Intervention/treatment Phase
More Effective Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination More Prolonged Duration of Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination Procedure: Modified pec11 trunk block Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 3, 2020

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Arm Intervention/treatment
Active Comparator: Modified pec 11 trunk block using ketamine additive
Ultasound guided modified pec 11 trunk block using ketamie hydrochoride 1mg/kg in 2ml volume added to 30ml bupivacaine 0.25% for trunk analgesia
Procedure: Modified pec11 trunk block
Ultrasound guided modified pec 11 block injecting local anesthetic with or without adjuvant between pectoralis minor and serratus anterior muscles

Active Comparator: Modified pec 11trunk block using dexmedetomidine additive
Ultasound guided modified pec 11 trunk block using dexmedetomidine 1ug/kg in 2ml volume added to 30ml bupivacaine 0.25%
Procedure: Modified pec11 trunk block
Ultrasound guided modified pec 11 block injecting local anesthetic with or without adjuvant between pectoralis minor and serratus anterior muscles

Active Comparator: Modified pec 11trunk block without additive
Ultasound guided modified pec 11 trunk block using bupivacaine 0.25% added to 2ml saline
Procedure: Modified pec11 trunk block
Ultrasound guided modified pec 11 block injecting local anesthetic with or without adjuvant between pectoralis minor and serratus anterior muscles




Primary Outcome Measures :
  1. Total postoperative morphine consumption over the first 24 hours postoperative [ Time Frame: "through study completion ,an average of one year" ]
    number value

  2. The time to first request of analgesic postoperatively [ Time Frame: "through study completion ,an average of one year" ]
    time


Secondary Outcome Measures :
  1. pain scores at rest and active movement of ipsilateral arm [ Time Frame: "through study completion ,an average of one year" ]
    number value

  2. intraoperative fentanyl requirements [ Time Frame: "through study completion ,an average of one year" ]
    number value



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients ASA1,11,111 between 18 and 60 years scheduled for modified radical mastectomy

Exclusion Criteria:

  • Patients with history of advanced cardiac disease
  • Patients having sepsis,
  • Patients with prior surgery in areas above or below the clavicle or in the axillary region,
  • Patients with opioid dependence or alcohol or drug abuse,
  • Patients with coagulopathy
  • Patients with psychiatric illness that prevent them from proper perception and assessment of pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380168


Locations
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Egypt
Ain Shams university Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Amira Fathy Hefni,MD-EDIC, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04380168    
Other Study ID Numbers: FMASU R 24/2019
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Pain