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NCT Number: NCT06957041

Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intertransverse Process Block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wing Sum Li, MBChB, BA

CONTACT

[email protected]

852-55699340

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: ITPB QoR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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