Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy
Condition: Dexmedtomidine in Erector Spinae Block for Laparscopic Cholecystectomy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sixty patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned
      using sealed envelope into two equal groups (30 patients each).

      Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in
      each site of injection .

      Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus
      2ml dexmedetomidine 0.5 ug /kg in each site of injection .
    

Detailed description: 
      This prospective randomized study will be carried out in general surgery Department within 6
      months from January 2022 to June 2022 on the 60 patients scheduled for elective laparoscopic
      cholecystectomy . A written informed consent will be obtained from the patients. Every
      patient will receive an explanation to the purpose of the study and will have a secret code
      number and the photos applied only to the part of the body linked to the research to ensure
      privacy to participants and confidentiality of data.

      Research results will be only used for scientific purposes. Procedures will be approved by
      both the Institutional and the Regional ethical committees.

      The risk that may occur is minimal, inadequate analgesia and this risk will be overcome by
      tramadol 50 mg intravenously STAT dose. Any unexpected risk appears during the course of the
      research will be cleared to the participants and ethical committee on time and proper
      measures will be taken to overcome or minimize these risks.

      The research end point when reach desired lower pain score postoperative without occurance of
      any complication as heamodynamic instability.

      . Preanesthetic checkup and routine investigations, such as complete blood count test, liver
      &kidney function test and coagulation profile, will be done. Patients will be kept fasting
      for 8 h.

      On arrival in the operative room, standard monitoring equipment will be attached
      (electrocardiogram, pulse oximeter, and noninvasive blood pressure) and baseline vital
      parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure
      (DBP), respiratory rate (RR), and oxygen saturation (SpO2) will be noted just before
      induction of anesthesia. Peripheral venous access will be obtained IV crystalloid at rate 10
      ml\kg will be infused.

      Technique of ultrasound guided Erector spine plane block:

      The pa¬tient will be placed in sitting position and the ultrasound-guided ESP block was
      performed bilaterally at the (T7) level. A 23 G spinal needle was inserted with the bevel in
      cephalo- caudal direction .

      Sixty patients will be randomly assigned using sealed envelope into two equal groups (30
      patients each).

      Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in
      each site of injection .

      Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus
      2ml dexmedetomidine 0.5 ug /kg in each site of injection .

      Anesthesia will be induced with injection of propofol 2 mg/kg, and fentanyl 1ug/kg
      intravenous (I.V) Endotracheal intubation will be facilitated with injection rocuronium
      bromide 0.9 mg/kg IV. Anesthesia will be maintained with in O2 with sevoflurane 2% to
      maintained BIS 40-60. Neuromuscular relaxation will be maintained with injection rocuronium
      top ups of 0.3 mg i.v every hour.

      The lungs will be mechanically ventilated to keep end-tidalCO2 within normal range and
      residual neuromuscular block will be reversed with injection neostigmine (0.05 mg/kg) and
      injection atropine (0.01 mg/kg). The patients will be extubated when respiration deemed
      sufficient. The patients will be transferred to recovery room. In the post anesthesia care
      unit(PACU), they will be monitored for any evidence of complications or adverse events and
      discharged when aldert score ≥ 9.
    

Intervention name(s): dexmedetomidine as adjuvant with bupivacaine; Bupivacain only
Intervention type(s): Drug; Drug
Intervention description(s): to assess efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.; to assess efficacy of bupivacain alone in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dexmedtomidine-erector spinae block-cholecystectomy