Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.

June 7, 2023 updated by: Ehab Hanafy Shaker, National Cancer Institute, Egypt

Comparative Study Between Dexmedetomedine and Ketamine in Erector Spinae Plane Block for Postoperative Analgesia Following Modified Radical Mastectomy. A Prospective Randomized Controlled Study.

Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.

Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain.

A systematic review and meta-analysis of experimental studies showed that the provision of effective analgesia reduces both the number and incidence of metastases in experimental cancer models . Pain may influence body homeostasis and cancer progression by pain-related immune suppression.

General anesthesia is the conventional, most frequently used anesthetic technique in breast cancer surgical interventions. Various regional anesthetic techniques have also been used; these include local wound infiltration, thoracic epidural anesthesia, paravertebral block (PVB), thoracic spinal anesthesia, and more recently, ultrasound-guided interfacial plane blocks such as pectoral nerve (PECS) blocks type 1 and 2 and the serratus plane block (SPB). Recently introduced erector spinae plane block (ESPB) requires less technical expertise (easy), and may be a safe alternative to PVB. ESP block is described for treating thoracic neuropathic pain with encouraging results. ESP is a potential space deep to erector spinae muscle (ES), where the injected local anaesthetic (LA) spreads cranio-caudally up to several levels as the ES fascia extends from nuchal fascia cranially to the sacrum caudally (C7-T2 cranially and L2-L3 caudally), The block covers somatic and visceral pain during breast surgery blocks by blocking ventral rami, dorsal rami of spinal nerves, and rami communicans that transmit sympathetic fibers.

There is another potentially beneficial effects of regional anaesthesia and analgesia on perioperative outcomes, these include decreased opioids consumption , lower rate of post-operative pulmonary complications, decreased post-operative nausea vomiting (PONV) and decreased duration of post-anaesthesia care unit stay. Regional anaesthesia has long-term oncological outcomes as it is considered protective for cancer recurrence by its indirect and direct antiproliferative effects.

Over recent years, the addition of multiple types of additives to local anesthetics has been reported to improve analgesic effect of peripheral nerve block and regional blocks Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.

Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12588
        • Hanafy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I or II .
  • female aged between 18 to 65. Scheduled for elective modified radical mastectomy under general anesthesia.

Exclusion Criteria:

  • Patient known to have allergy to any of the drugs used in the study.
  • Infection at injection site.
  • Coagulation disorders.
  • severe heart ,liver or kidney disease.
  • Unwillingness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
Will receive ultrasound guided ESPB with 0,25% Bupivacaine .
Drug: Bupivacaine Hydrochloride
injection of Bupivacaine 0.25% in ESPB
Other Names:
  • local anesthetic
Active Comparator: Bupivacaine and dexmedetomedine
Will receive ultrasound guided ESPB with 0,25% Bupivacaine + Dexmedetomidine.
Drug: Bupivacaine Hydrochloride and dexmedetomedine
injection of Bupivacaine 0.25% and dexmedetomedine in ESPB
Other Names:
  • local anesthetic and dexmedetomedine
Active Comparator: Bupivacaine and Ketamine
will receive ultrasound guided ESPB with 0,25% Bupivacaine + Ketamine.
Drug: Bupivacaine Hydrochloride and ketamine
injection of Bupivacaine 0.25% and ketamine in ESPB
Other Names:
  • local anesthetic and ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia request postoperative
Time Frame: 24 hours
the time of first rescue analgesia
24 hours
Total opioid consumption
Time Frame: 24 hours
Total opioid consumption
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale.
Time Frame: 24 hours
Calculation of Visual analogue scale at rest and mouvement. It is 10 points scale from 0 to 10 where 0 represents no pain while 10 represents maximum pain
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Ehab H Shaker, MD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erector block after mastectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After data publication upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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