Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong
About this trial
The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by:
Primary Objective:
Primary outcome measure:
● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours
Secondary outcome measure:
* Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge * Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow. * Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours * Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU)
Hypothesis:
The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patient refusal
Patients who are unable to comprehend the QoR15 form
Local or systemic infection
Coagulopathy leading to absolute contraindication to regional anesthesia
Trial design
Design model
Single group
Treatments tested in this trial
Intertransverse process block
Procedure/SurgeryThe patient(s) will receive a pre-induction Intertransverse process block as pilot study
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Open Hepatectomy Patient receiving the intertransverse process blockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Recovery (QOR-15)
The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR). The QoR-15 has since become the most widely reported measure of patient-assessed QoR after surgery. QoR-15 has no units.
Time frame
24 and 48 hoursSecondary outcomes
1
Dermatomal blockade on Thorax 30 minutes upon block completion
To assess the number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge. This will be done by ice block test. The blockade is considered positive if patient has a reduction in cold sensation over the tested dermatome compared to non-blocked areas such as forehead.
Time frame
Up to 30 minutes after block completion2
24 hours area under curve of postoperative pain score
Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow.
Time frame
Up to 24 hours3
Morphine consumption at 24 and 48 hours postoperatively
Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
Time frame
At 24 and 48 hours postoperatively4
Time to discharge from HDU / ICU
Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU) up to 5 days
Time frame
Up to 5 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: