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Completed

NCT Number: NCT04920669

Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, Egypt

About this study

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Female, aged (18-70) years
  • Belongs to American Society of Anaesthesiologists physical status class II.
  • Scheduled for breast cancer surgeries.

Exclusion criteria

  • Patient refusal.
  • Local infection at the site of the block.
  • Cardiac dysfunction (ejection fraction <45%).
  • Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
  • Allergy to one of the study drugs.
  • Pregnancy.
  • Coagulopathy (PC <60% and platelet count<100.000).

Treatment and study plan

erector spinae block with bupivacaine

Procedure

Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%

erector spinae block with bupivacaine + dexmedetomidine

Procedure

Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine

Primary outcomes

  1. Time to first request of analgesia

    Time frame: The first postoperative day

    Time from recovery of anesthesia till first request for analgesia to relive pain.

Secondary outcomes

  1. Total morphine consumption in first postoperative 24 hours

    Time frame: First 24 postoperative hours

    The amount of morphine required to relieve pain will be recorded

  2. Intraoperative fentanyl requirement

    Time frame: During anesthesia

    The amount of fentanyl required during anesthesia will be recorded

  3. Numerical rating scale

    Time frame: The first 24 postoperative hours

    Numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Mohamed Elsayed Hassan

Other

Registry information

Official study title

Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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