PVB Versus TAP in Hepatic Patients Undergoing Laparoscopic Cholecystectomy

NCT04208165 | Completed

• 1 other identifier: TBRI 118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Hepatic Impairment; Laparoscopic Cholecystectomy

Keywords

Ultrasound- guided; PVB; TAP; Hepatic; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score

  Postoperative pain will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain) on coughing.

  2 hours after surgery.

Secondary Outcomes (3)

• Intra-operative fentanyl (analgesic) consumption

  During the operation

• Total desflurane (anesthetic) consumption

  From start of desflurane application til the end of surgery.

• Postoperative pethidine (analgesic) consumption

  24 hours after operation

Study Arms (2)

Group P (ultrasound-guided PVB)

ACTIVE COMPARATOR

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

Group T (ultrasound-guided TAB)

ACTIVE COMPARATOR

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

Interventions

ultrasound-guided nerve block PVB OTHER

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.

Group P (ultrasound-guided PVB)

ultrasound-guided nerve block TAB OTHER

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.

Group T (ultrasound-guided TAB)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead
• Cairo University: collaborator

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Study Officials

• Hanan F. Khafagy, Prof.

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 23, 2019
• Study Start: December 29, 2019
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)