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PVB Versus TAP in Hepatic Patients Undergoing Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208165
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Hanan Farouk Khafagy, Theodor Bilharz Research Institute

Brief Summary:
The Era of using ultrasound guided blocks provides an attractive and more or less safe alternative to other techniques. Among these blocks is ultrasound-guided transverse abdominis plane block (USG-TAP block) that controls pain by local anesthetic injection into the neurofascial plane of the abdominal muscles. Ultrasound-guided thoracic paravertebral block (USG-TPVB) is another technique in which local anesthetic is injected nearby the thoracic vertebra where spinal nerve emerges from the intervertebral foramina. It provides ipsilateral somatic and sympathetic blockade in many dermatomes around the injection site. The aim of this study is to verify which technique is more efficient in reducing the intra- and postoperative analgesic requirements in hepatic patients.

Condition or disease Intervention/treatment Phase
Ultrasound Therapy Hepatic Impairment Laparoscopic Cholecystectomy Other: ultrasound-guided nerve block PVB Other: ultrasound-guided nerve block TAB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Ultrasound Guided Paravertebral Block Versus Transverse Abdominis Plane Block in Hepatic Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date : December 29, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Group P (ultrasound-guided PVB)
In group P, the patient is in sitting position, a linear transducer (6-15 MHz) placed just lateral to the spinous process. Once the transverse processes and ribs are identified, the transducer is moved slightly cauded into the intercostal space between adjacent ribs to identify the thoracic paravertebral space (PVS) and the adjoining intercostal space. The hyper echoic line of the pleura and underlying hyper echoic air artifacts move with respiration. The needle stimuplex needle will be inserted and 0.5- 1 ml local anesthetic injection administered to show the displacement of pleura downward followed by 15 cc bupivacaine 0.25% into each side the PVS. A pop often is felt as the needle penetrates the internal intercostal membrane. Intravascular injection will be eliminated by negative aspiration before injection. Local anesthetic (15- 20 ml) is slowly injected in small increments, avoiding forceful high-pressure injection to reduce the risk of bilateral epidural spread.
Other: ultrasound-guided nerve block PVB
Thoracic paravertebral block guided by ultrasound device which allows visualizing the surrounding anatomy and placement of the needle at the target location in real time.

Active Comparator: Group T (ultrasound-guided TAB)
In group T, Subcostal blockage will be done in plane technique with 22 G needle (BRAUN Stimuplex D Plus 0,71 50- 80 mm 22 G). The puncture area and the ultrasound probe will be prepared in an aseptic manner. The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. On each side, The rectus abdominis and underlying transverses abdominis muscles near the costal margin and xiphoid process will be identified. In-plane image will be obtained and the needle will be inserted through the rectus muscle 2-3 cm medial to the probe. Once the tip of the needle is visualized to be in the plane, 0.25% bupivacaine will be administered incrementally. The drug will be injected along the oblique subcostal line, extending inferolaterally from the xiphoid towards the anterior part of the iliac crest by multiple punctures; a total of 15 ml will be given on each side.
Other: ultrasound-guided nerve block TAB
Transverse abdominis plane block guided by ultrasound device which allows visualizing the surrounding anatomy and placement of the needle at the target location in real time.




Primary Outcome Measures :
  1. Postoperative pain score [ Time Frame: 2 hours after surgery. ]
    Postoperative pain will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain) on coughing.


Secondary Outcome Measures :
  1. Intra-operative fentanyl (analgesic) consumption [ Time Frame: During the operation ]
    The total amount of fentanyl (micro-gram) consumption throughout operation. Fentanyl will be given at induction in a dose 1.5- 2 µg / kg fentanyl. When heart rate and blood pressure exceeds 20% of baseline in spite of adequate anesthesia level, boluses of 0.5 µg/kg fentanyl will be given

  2. Total desflurane (anesthetic) consumption [ Time Frame: From start of desflurane application til the end of surgery. ]
    Amount of consumed desflurane (CC) according to the formula: (Fresh gas flow (liter/min) X vaporizor (%) X1000 )/(Conversion factor) dt.

  3. Postoperative paracetamol (analgesic) consumption [ Time Frame: 24 hours after operation ]
    Total amount of paracetamol (mg). If NRS is more than 4, intravenous paracetamol 15 mg/kg will be given.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Elective laparoscopic cholecystectomy surgery.
  2. Age: adult patients between 20 - 65 years old.
  3. Gender: Both male and female.
  4. ASA Class: II.
  5. hepatic patients child A or B

Exclusion Criteria:

  1. Refusal of patient.
  2. Pregnancy and lactation.
  3. Fever or sepsis.
  4. Patients ASA class III and IV.
  5. Child C hepatic patients
  6. Addicts and drug abusers.
  7. Patients taking corticosteroids or any cardio - active drugs.
  8. Local infection at site of the injection.
  9. Allergy to any of the study medications.
  10. Severe coagulopathy
  11. kyphoscliosis concerning the paravertebral group will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208165


Contacts
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Contact: Haitham A. Abouzeid, Prof. 00201065455387 haithamabouzeid@gmail.com
Contact: Reeham S. Ebied, Prof. 00201222192667 drreeham@yahoo.com

Locations
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Egypt
Theodor Bilharz Research Institute Recruiting
Giza, Egypt, 12411
Contact: Wafaa Kandeel, Dr.    0020235407270    itc@tbri.gov.eg   
Contact: Haitham A Abouzeid, Dr    00201065455387    haithamabouzeid@gmail.com   
Sponsors and Collaborators
Theodor Bilharz Research Institute
Cairo University
Investigators
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Principal Investigator: Hanan F. Khafagy, Prof. Theodor Bilharz Research Institute
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Responsible Party: Hanan Farouk Khafagy, Professor doctor, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT04208165    
Other Study ID Numbers: TBRI 118
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanan Farouk Khafagy, Theodor Bilharz Research Institute:
Ultrasound- guided
PVB
TAP
Hepatic
Laparoscopic Cholecystectomy