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Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03393988
Enrollment
20
Registered
2018-01-09
Start date
2017-12-07
Completion date
2019-02-28
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Transversus abdominis plane block,, Dexmedetomidine, Fentanyl, Live liver donor, Liver transplantation

Brief summary

This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.

Interventions

After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).

After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.

DRUGDexmedetomidine

Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesia (ASA) physical status I or II * Scheduled as live liver donors * J-shaped incision in the supraumblical region

Exclusion criteria

* Patients with a history of psychiatric/neurological illness, * Hypertensive patients, * Morbidly obese patients, * Pregnant and nursing women, * Patients with known allergic reaction to any of the study medications, * Patients on recent use of sedatives or analgesics, * Patients with significant laboratory abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Total fentanyl consumptionIntraoperativeTotal Intravenous fentanyl consumption during the operation

Secondary

MeasureTime frameDescription
Average sevoflurane concentrationIntraoperativeThe average sevoflurane concentration (the average concentration (%) for the case will be determined from the vaporizer setting recorded in the anesthetic record per 5-minute interval)
The severity of postoperative nausea and vomiting (PONV)First 24 hours postoperativelyWill be recorded and classified as no PONV, mild PONV, moderate PONV and severe PONV
Ramsay sedation score (RSS)First 24 hours postoperativelyWill be used for assessment of sedation immediately after extubation, after 2 hours of ICU admission, after 12 hours then after 24 hours .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026