Analgesic Efficacy of Dexmedetomidine as Adjuvant to Levobupivacaine in Ultrasound-guided Erector Spinae Plan Block for Modified Radical Mastectomy

To evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.

Study Overview

• Status: Unknown
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: erector spinae block with bupivacaine; Procedure: erector spinae block with bupivacaine and dexmedetomidine

Detailed Description

Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ECG, temperature and capnography), an intravenous cannula will be placed and secured.

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) No other narcotic, analgesic or sedative will be administrated during operative period.

Standard monitor (mean arterial blood pressure, heart rate , oxygen saturation & end-tidal Co2) will observed and recorded every 30 min till end of surgery

Post-operative:

The patient will be transferred to the post anesthesia care unit (PACU) and will be monitored for:

1. Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).
2. RASS score (Richmond Agitation & Sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1)
3. Numerical Rating Score (NRS) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1). (4)Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3. (5) Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 171516
    • Recruiting
    • South Egypt Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female patient
• American society of anesthesiologists (ASA) I and II physical status
• age from 25 to 70 years old
• scheduled for either left or right modified radical mastectomy (MRM).

Exclusion Criteria:

• infection of the skin at or near site of needle puncture,
• coagulopathy,
• drug hypersensitivity or allergy to the studied drugs,
• central or peripheral neuropathy,
• significant organ dysfunction cardiac dysrrhythmias,
• obesity (BMI>35kg/m2)
• recently use analgesic drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: GROUP(A) (CONTROL GROUP); Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.	Procedure: erector spinae block with bupivacaine; Group (A) (control group): Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
Active Comparator: Group (D); Patient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.	Procedure: erector spinae block with bupivacaine and dexmedetomidine; Patient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia required	time of first request for analgesia.	24 hours

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 28, 2021
• Study Completion (Anticipated): December 28, 2021

Study Registration Dates

• First Submitted: January 9, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: peter 3 SECI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No