PVB Versus TAP in Hepatic Patients Undergoing Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT04208165|
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : January 28, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Haitham A. Abouzeid, Prof.||firstname.lastname@example.org|
|Contact: Reeham S. Ebied, Prof.||email@example.com|
|Principal Investigator:||Hanan F. Khafagy, Prof.||Theodor Bilharz Research Institute|