Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy (ITPB QoR)

April 25, 2025 updated by: Wing Sum Li, Chinese University of Hong Kong

Effect of Intertransverse Process Block on the Quality of Recovery Post-Open Hepatectomy: A Pilot Non-Randomised Study of Intervention

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Adult patients aged 18-75 years of ASA I - III physical status classification undergoing open hepatectomy for benign or malignant liver lesion.

Exclusion Criteria:

  • Patient refusal
  • Patients who are unable to comprehend the QoR15 form
  • Local or systemic infection
  • Coagulopathy leading to absolute contraindication to regional anesthesia
  • Contraindication to local anaesthetics (LA) such as LA allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Hepatectomy Patient receiving the intertransverse process block
Procedure: Intertransverse process block
The patient(s) will receive a pre-induction Intertransverse process block as pilot study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery (QOR-15)
Time Frame: 24 and 48 hours
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.
24 and 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatomal blockade on Thorax 30 minutes upon block completion
Time Frame: Up to 30 minutes after 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.
Up to 30 minutes after block completion
24 hours area under curve of postoperative pain score
Time Frame: Up to 24 hours
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.
Up to 24 hours
Morphine consumption at 24 and 48 hours postoperatively
Time Frame: At 24 and 48 hours postoperatively
Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
At 24 and 48 hours postoperatively
Time to discharge from HDU / ICU
Time Frame: Up to 5 days
Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU) up to 5 days
Up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CRE Ref. No. 2024.562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatectomy

Clinical Trials on Intertransverse process block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe