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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04275661
Enrollment
60
Registered
2020-02-19
Start date
2020-08-01
Completion date
2022-04-30
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Breast Cancer

Brief 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.

Detailed 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

Interventions

PROCEDUREUltrasound (US) bi-level erector spinae block

nerve block

DRUGlevobupivacaine

20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle

DRUGKetamine

2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle

DRUGMagnesium Sulfate

2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
total morphine consumption in first 48 hours48 hoursdetermine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
time to first request of analgesia48 hours

Countries

Egypt

Contacts

STUDY_DIRECTORkhaled fares

Assiut University

STUDY_DIRECTORhamdy abbas

Assiut University

STUDY_DIRECTORfatma adel

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026