A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy

October 19, 2018 updated by: Nanfang Hospital of Southern Medical University

A Randomized Controlled Trial Comparing Quadratus Lumborum Block and Paravertebral Block for Postoperative Analgesia in Laparoscopic Hepatectomy and Open Hepatectomy

Pain after hepatectomy can interfere with the patients' recovery and may contribute to developing long term pain. Opioids, e.g. morphine, fentanyl, sufentanil, works well for postoperative analgesia, but have several side effects such as nausea, vomiting and itching which may be severe enough to affect patients' recovery. In some cases, opioids may cause constipation and urinary retention within the first 24 hours after surgery. Thus, several ultrasound-guided nerve block procedures have been applied to provide postoperative analgesia. Ultrasound-guided thoracic paravertebral block (TPVB) is one of the most used nerve block methods using for post-hepatectomy analgesia. However, in some cases, ultrasound-guided TPVB can cause pneumothorax, hemopneumothorax, and higher block level. The quadratus lumborum block (QLB) is a new developed nerve block which can provide a widespread analgesic effect from T7 to L1. Therefore, this study is to determine whether QLB or TPVB have a better pain control with fewer side effects and complications after laparoscopic and open hepatectomy. The adequate pain control will be assessed by their visual analogue score (VAS) and the postoperative quality of recovery scale (QoR-15, Chinese Version). Additionally, the side effect and complications profile of these two nerve block techniques will also be recorded and compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

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

  • Name: Junyun Fan, Bachelor
  • Phone Number: 86-020-627864 0086-15920091179
  • Email: 381774142@qq.com

Study Contact Backup

  • Name: Bingsha Chen, Bachelor
  • Phone Number: 0086-15802031635
  • Email: 1550688601@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
        • 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 65 years old for selective hepatectomy from nanfang Hospital, Southern Medical University
  • American Society of Anesthesiologists (ASA) risk class I-III;
  • Body Mass Index (BMI) is not lesser than 18 and not greater than 30;

Exclusion Criteria:

  • Patients refuse to participate
  • Allergy to the any agents used in current clinical trial;
  • Dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs;
  • Patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.);
  • Previous abdominal surgery (except for diagnostic biopsy);
  • New York Heart Association (NYHA) classification of cardiac function grade IV and/or Ejection Fraction (EF)≤55%;
  • Child-Pugh grading
  • Liver function of grade C (Child-Pugh grading)
  • Glomerular filtration rate≤60ml/min/1.73m2;
  • Obstructive sleep apnea syndrome;
  • Chronic obstructive pulmonary disease, asthma, active tuberculosis;
  • Cardiac rhythm disorders;
  • Past or present history of nervous system diseases and mental disorders (such as epilepsy, Alzheimer's disease, Parkinsonism syndrome, depression,etc.);
  • Autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.)
  • Malignant tumors of other systems;
  • Other operations are required during the same period;

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: PCA for Open Hepatectomy
Patient-controlled intravenous analgesia in Open hepatectomy (PCA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
EXPERIMENTAL: QLB for Open Hepatectomy
Bilateral quadratus lumborum block with 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Other: Quadratus Lumborum Block
Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
EXPERIMENTAL: TPVB for Open hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Other: Thoracic Paravertebral Block
Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.
OTHER: PCA for Laparoscopic Hepatectomy
Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
EXPERIMENTAL: QLB for Laparoscopic Hepatectomy
Bilateral quadratus lumborum block 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Other: Quadratus Lumborum Block
Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
EXPERIMENTAL: TPVB for Laparoscopic Hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Other: Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Other: Thoracic Paravertebral Block
Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: From 1 day before the surgery to the 2 days after surgery
The visual analogue scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In current study visual analogue scale is be adopt to assess pain of patients. The VAS ranges from 0-10,0 represents no pain and 10 represents the worst pain.
From 1 day before the surgery to the 2 days after surgery
QoR-15/Quality of Recovery Scale 15(QoR-15)
Time Frame: From 1 day before the surgery to the 2 days after surgery
The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (n = 2), physical comfort (n = 5), physical independence (n = 2), psychological support (n = 2), and emotional state (n = 4) . Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR.
From 1 day before the surgery to the 2 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioids consumption
Time Frame: From admitting in operation room to 48 hours after hepatectomy
The total amount of opioids consumed during perioperative period
From admitting in operation room to 48 hours after hepatectomy
Opioids consumption during hepatectomy Intraoperative opioids consumption
Time Frame: At the end of surgical procedure
Total doses of opioids consumed during the surgical procedure intraoperatively
At the end of surgical procedure
Opioids consumption after hepatectomy
Time Frame: Up to 48 postoperative hrs
Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order
Up to 48 postoperative hrs
First request of analgesia
Time Frame: Up to 48 postoperative hrs
Time to first request of rescue analgesic drug
Up to 48 postoperative hrs
Nausea
Time Frame: Up to 48 postoperative hrs
Incidence of postoperative nausea
Up to 48 postoperative hrs
Vomiting
Time Frame: Up to 48 postoperative hrs
Incidence of postoperative vomiting
Up to 48 postoperative hrs
Respiratory depression
Time Frame: Up to 48 postoperative hrs
Incidence of postoperative respiratory depression
Up to 48 postoperative hrs
Pruritus
Time Frame: Up to 48 postoperative hrs
Incidence of postoperative pruritus
Up to 48 postoperative hrs
Sedation Score
Time Frame: Up to 48 postoperative hrs
A score to evaluate patients' sedation deepness Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. The OAA/S Scale is composed of the following categories: (1) responsiveness, (2) speech, (3) facial expression, and (4) eyes. The OAA/S Scale can be scored in two ways: the composite score, with a range of 1 (deep sleep) to 5 (alert), in any one of the four assessment categories and the sum of the four component scores, where responsiveness has possible scores of 1, 2, 3, 4 or 5, speech has scores of 2, 3, 4 or 5, and facial expression and eyes have scores of 3, 4 or 5.
Up to 48 postoperative hrs
Time to first off-bed activity
Time Frame: Up to discharge from hospital
Postoperative activity
Up to discharge from hospital
Lower extremity muscle strength
Time Frame: Up to 48 postoperative hrs
The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.
Up to 48 postoperative hrs

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Tao Tao, MD, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

May 9, 2018

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2017-190

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.

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