Clincosm LogoSign in Get a demo

Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04719507
Collaborator
(none)
45
Enrollment
3
Arms
13.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the study aims to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block after open nephrectomy surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: erector spinae block
  • Procedure: thoracic paravertebral block
  • Drug: Pethidine Only Product in Parenteral Dose Form
 N/A

Detailed Description

Open nephrectomy is associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension ,headache ,nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting ,constipation, allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank(T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10).

Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent anecdotal reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami .According to a previous study, Erector Spinae Plane block has allowed a reduction in opioid consumption and excellent pain control in partial nephrectomy.

Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic.

PVB is effective for pain relief in the thoracic, abdominal and limb regions .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: erector spinae arm

ultrasound guided erector spinae block

Procedure: erector spinae block
ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 3 cm laterally to obtain the appropriate visualization. Under aseptic precautions, the needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine is administered in cephalad and caudal directions.
Other Names:
  • erector spinae plane block

    		•
    Experimental: thoracic paravertebral arm

    ultrasound guided thoracic paravertebral block.

    Procedure: thoracic paravertebral block
    ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle is inserted cranial to caudal direction using in-plane approach . After confirming the displacement of pleura with 0.5-1 ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine is administered for the block.
    Active Comparator: drug arm

    pethidine (1 mg/kg ) once

    Drug: Pethidine Only Product in Parenteral Dose Form
    pethidine (1 mg/kg ) once

    Outcome Measures

    Primary Outcome Measures

    1. Total morphine requirements 24 hours postoperatively [24 hours postoperative]

      morphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at <3 and the total 24-hours morphine consumption will be recorded

    Secondary Outcome Measures

    1. Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively [2, 4, 6, 12, 18, and 24 hours postoperatively]

      the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity .no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

    2. Time span to the first postoperative analgesia [calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours]

      Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine

    3. operation time [from start of anesthesia till the end of surgery , expected from 3-4 hours]

      Duration of the anesthesia and surgery to be documented

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult patients (30-60 years) .

    • Patients with ASA I , II score

    Exclusion Criteria:

    • Patient's refusal

    • Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )

    • Infection at the injection site.

    • Allergy to local anesthetics.

    • Patients receiving opioids for chronic analgesic therapy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ezzat Ramzy Ezz, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04719507
    Other Study ID Numbers:
    • pain control in nephrectomy
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ezzat Ramzy Ezz, principle investigator, Cairo University
    open nephrectomy
    Additional relevant MeSH terms:
    Pain, Postoperative
    Meperidine

    Study Results

    No Results Posted as of Jan 22, 2021