Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy

NCT06957041 | Not Yet Recruiting

• 1 other identifier: CRE Ref. No. 2024.562
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatectomy; Intertransverse Process Block; Quality of Recovery (QoR-15)

Outcome Measures

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.

  24 and 48 hours

Secondary Outcomes (4)

• Dermatomal blockade on Thorax 30 minutes upon block completion

  Up to 30 minutes after block completion

• 24 hours area under curve of postoperative pain score

  Up to 24 hours

• Morphine consumption at 24 and 48 hours postoperatively

  At 24 and 48 hours postoperatively

• Time to discharge from HDU / ICU

  Up to 5 days

Study Arms (1)

Open Hepatectomy Patient receiving the intertransverse process block

EXPERIMENTAL

Procedure: Intertransverse process block

Interventions

Intertransverse process block PROCEDURE

The patient(s) will receive a pre-induction Intertransverse process block as pilot study

Open Hepatectomy Patient receiving the intertransverse process block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Central Study Contacts

Wing Sum Li, MBChB, BA

CONTACT

852-55699340; vickiliwingsum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04