Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04275661
• Other study ID #: ESPB in breast cancer surgery
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: April 2022

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.

Description:

The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.

Group (C) / (I): 20 patients (control group):

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.

Group (K) / (II): 20 patients (Ketamine group):

Patient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.

Group (M) / (III): 20 patients (magnesium sulphate group):

Patient will receive 20ml 0.25% levobupivacaine as above + 2mg/kg MgSo4.

Study protocol:

Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery. ECG, temp, and capnography), an intravenous cannula will be placed and secured in the opposite side to surgery.

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth and seventh spinous process, then Trapezious m., Rhomboideus major muscle, and erector spinae muscle, are identified from surface, we will deposite 20 ml of 0.25% levobupivacairen into interfacial plane below erector spinae muscle.

General anesthesia will be induced with lμg/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium inhalational anesthesia (isoflurane or sevoflurane)

1gm paracetamol after induction No other narcotic, analgesic or sedative will be administrated during operative period.

Standard monitor (MABP, HR , SaO2 & EtCo2) will be observed and recorded every 30 min till end of surgery Post-operative ; the patient will be transferred to the post anesthesia care unit (PACU). In PACU the following data included heart rate, mean blood pressure, respiratory rate and oxygen saturation and VAS scores (at rest and after movement in the form of abduction of ipsilateral arm ) at baseline,2,4,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. The attending anesthesiologist, surgeon and the data collecting personal will be unaware of the patient assignment.

Rescue post-operative analgesia in the form of morphine Patient controlled analgesia (PCA ) with an initial bolus of 0.1 mg/ kg morphine once pain is expressed followed by 1mg bolus with a locked period of 15 minutes with no back ground infusion allowed. The time to first request of analgesia and the total analgesic consumption in the 1st 48 hour will be observed and recorded. Postoperative adverse effects will be observed and treated

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age of 18 - 60 years.

• ASA grade I - II.

Exclusion Criteria:

• Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness that would interfere with perception and assessment of pain.

Related Conditions & MeSH terms

• Analgesia
• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Ultrasound (US) bi-level erector spinae block
nerve block

Drug:
• levobupivacaine
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
• Ketamine
2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle
• Magnesium Sulfate
2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle

Locations

Country	Name	City	State
Egypt	south Egypt Cancer Institute Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Altiparmak B, Korkmaz Toker M, Uysal AI, Gümüs Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6). pii: e228129. doi: 10.1136/bcr-2018-228129. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine consumption in first 48 hours	determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption	48 hours
Primary	time to first request of analgesia		48 hours