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Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04635644
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane Block
  • Procedure: Intrathecal morphine
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Erector Spinae Plane Block

Patients will receive Erector spinae plane block.

Procedure: Erector Spinae Plane Block
Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.
Other Names:
  • ESP block

    		•
    Active Comparator: Intrathecal morphine ITM

    Patients will receive Intrathecal morphine.

    Procedure: Intrathecal morphine
    Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.
    Other Names:
  • ITM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative opioid consumption [24 hours postoperatively]

      Nalbuphine consumption in mg equivalent to morphine dose

    Secondary Outcome Measures

    1. Nalbuphine consumption in mg [at 8, 48, and 72 hours postoperatively.]

      equivalent to morphine dose

    2. Analgesic drug consumption other than nalbuphine [at 8, 24, 48, and 72 hours postoperatively.]

      consumption in mg

    3. Numerical Rating Scale (NRS) at rest and when coughing [at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively]

      NRS is an 11-point (0=no pain and 10=worst pain)

    4. Heart Rate [Intraoperatively]

      Heart Rate in beats /min

    5. Mean Arterial Pressure [Intraoperatively]

      Mean Arterial Pressure in mmHg

    6. Incidence of Postoperative nausea & vomiting (PONV) [24 hours postoperatively]

      Number of patients developing PONV

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,

    • patients with the American Society of Anesthesiologists (ASA) physical status I - II,

    • Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.

    Exclusion Criteria:

    • Patient's refusal

    • Allergy or contraindications to the study drugs,

    • Infection at the site of injection,

    • Coagulopathy,

    • Psychiatric disorders

    • Severely co-morbid patients,

    • Chronic pain syndromes,

    • Prolonged opioid medication,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University hospital Assiut Asyut Governorate Egypt 11111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Magdy Mohammed Mahdy Sayed, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04635644
    Other Study ID Numbers:
    • ABC-4-DE
    First Posted:
    Nov 19, 2020
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Morphine

    Study Results

    No Results Posted as of Nov 18, 2021