Quadratus Lumborum BlockNCT03540537
A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy
A study testing Quadratus Lumborum Block and Thoracic Paravertebral Block in people with Quadratus Lumborum Block and Thoracic Paravertebral Block, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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'… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quadratus Lumborum Block, Thoracic Paravertebral Block, Postoperative Analgesia
- What is being tested?
- Quadratus Lumborum Block and Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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%;
Show all 16Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Tao Tao, MD, 0086-18617391219, taotaomzk@smu.edu.cn
Bingsha Chen, Bachelor, 0086-15802031635, 1550688601@qq.com
About this study
Official title: 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.
- Conditions
- Quadratus Lumborum Block, Thoracic Paravertebral Block, Postoperative Analgesia, Hepatectomy
- Being tested
- Patient-controlled intravenous analgesia, Quadratus Lumborum Block, Thoracic Paravertebral Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled intravenous analgesiaOther
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
Quadratus Lumborum BlockOther
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.
Thoracic Paravertebral BlockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PCA for Open Hepatectomy | Other | 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) Receives: Other: Patient-controlled intravenous analgesia |
| QLB for Open Hepatectomy | Experimental | 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) Receives: Other: Patient-controlled intravenous analgesia; Other: Quadratus Lumborum Block |
| TPVB for Open hepatectomy | Experimental | 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) Receives: Other: Patient-controlled intravenous analgesia; Other: Thoracic Paravertebral Block |
| PCA for Laparoscopic Hepatectomy | Other | Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm) Receives: Other: Patient-controlled intravenous analgesia |
| QLB for Laparoscopic Hepatectomy | Experimental | 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) Receives: Other: Patient-controlled intravenous analgesia; Other: Quadratus Lumborum Block |
| TPVB for Laparoscopic Hepatectomy | Experimental | 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) Receives: Other: Patient-controlled intravenous analgesia; Other: Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
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.
Measured: From 1 day before the surgery to the 2 days after surgery
QoR-15/Quality of Recovery Scale 15(QoR-15)
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.
Measured: From 1 day before the surgery to the 2 days after surgery
Secondary outcomes (11)
Total opioids consumption
The total amount of opioids consumed during perioperative period
Measured: From admitting in operation room to 48 hours after hepatectomy
Opioids consumption during hepatectomy Intraoperative opioids consumption
Total doses of opioids consumed during the surgical procedure intraoperatively
Measured: At the end of surgical procedure
Opioids consumption after hepatectomy
Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order
Measured: Up to 48 postoperative hrs
First request of analgesia
Time to first request of rescue analgesic drug
Measured: Up to 48 postoperative hrs
Nausea
Incidence of postoperative nausea
Measured: Up to 48 postoperative hrs
Vomiting
Incidence of postoperative vomiting
Measured: Up to 48 postoperative hrs
Respiratory depression
Incidence of postoperative respiratory depression
Measured: Up to 48 postoperative hrs
Pruritus
Incidence of postoperative pruritus
Measured: Up to 48 postoperative hrs
Sedation Score
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.
Measured: Up to 48 postoperative hrs
Time to first off-bed activity
Postoperative activity
Measured: Up to discharge from hospital
Lower extremity muscle strength
The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.
Measured: Up to 48 postoperative hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start9 May 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540537
- Sponsor's protocol ID
- NFEC-2017-190
- Status last verified
- Feb 2018
- First submitted
- 18 Apr 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Go R, Huang YY, Weyker PD, Webb CA. Truncal blocks for perioperative pain management: a review of the literature and evolving techniques. Pain Manag. 2016 Oct;6(5):455-68. doi: 10.2217/pmt-2015-0012. Epub 2016 May 9.
PubMed 27156349Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.
PubMed 27891579El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus Lumborum Block Nomenclature and Anatomical Considerations. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):548-9. doi: 10.1097/AAP.0000000000000411. No abstract available.
PubMed 27315184Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
PubMed 26735154Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. No abstract available.
PubMed 27939905Cardoso JM, Sa M, Reis H, Almeida L, Sampaio JC, Pinheiro C, Machado D. [Type II Quadratus Lumborum block for a sub-total gastrectomy in a septic patient]. Braz J Anesthesiol. 2018 Mar-Apr;68(2):186-189. doi: 10.1016/j.bjan.2016.09.009. Epub 2016 Sep 28.
PubMed 27687315Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Dec;27(8):694-6. doi: 10.1016/j.jclinane.2015.05.006. Epub 2015 Jul 11. No abstract available.
PubMed 26174113La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
PubMed 27997495Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.
PubMed 27871532Chakraborty A, Khemka R, Datta T. Ultrasound-guided truncal blocks: A new frontier in regional anaesthesia. Indian J Anaesth. 2016 Oct;60(10):703-711. doi: 10.4103/0019-5049.191665.
PubMed 27761032Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.
PubMed 23927552Parras T, Blanco R. Randomised trial comparing the transversus abdominis plane block posterior approach or quadratus lumborum block type I with femoral block for postoperative analgesia in femoral neck fracture, both ultrasound-guided. Rev Esp Anestesiol Reanim. 2016 Mar;63(3):141-8. doi: 10.1016/j.redar.2015.06.012. Epub 2015 Aug 22. English, Spanish.
PubMed 26302669
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Quadratus Lumborum Block and Paravertebral Block for Postoperative Analgesia in Laparoscopic Hepatectomy and Open Hepatectomy
- ClinicalTrials.gov ID
- NCT03540537
- Acronym / sponsor ID
- NFEC-2017-190
- Conditions
- Quadratus Lumborum Block, Thoracic Paravertebral Block, Postoperative Analgesia, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PCA for Open Hepatectomy | Other | Other: Patient-controlled intravenous analgesiaPatient-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) |
| QLB for Open Hepatectomy | Experimental | Other: Patient-controlled intravenous analgesia, Other: Quadratus Lumborum BlockBilateral 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) |
| TPVB for Open hepatectomy | Experimental | Other: Patient-controlled intravenous analgesia, Other: Thoracic Paravertebral BlockT6+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) |
| PCA for Laparoscopic Hepatectomy | Other | Other: Patient-controlled intravenous analgesiaPatient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm) |
| QLB for Laparoscopic Hepatectomy | Experimental | Other: Patient-controlled intravenous analgesia, Other: Quadratus Lumborum BlockBilateral 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) |
| TPVB for Laparoscopic Hepatectomy | Experimental | Other: Patient-controlled intravenous analgesia, Other: Thoracic Paravertebral BlockT6+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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-controlled intravenous analgesiaPCIA 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 | PCA for Laparoscopic Hepatectomy, PCA for Open Hepatectomy, QLB for Laparoscopic Hepatectomy, QLB for Open Hepatectomy, TPVB for Laparoscopic Hepatectomy, TPVB for Open hepatectomy |
| Quadratus Lumborum BlockUltrasound-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. | Other | QLB for Laparoscopic Hepatectomy, QLB for Open Hepatectomy |
| Thoracic Paravertebral BlockUltrasound-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 | TPVB for Laparoscopic Hepatectomy, TPVB for Open hepatectomy |
Primary outcome
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.
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.
11 secondary outcomes
Total opioids consumption
Time frame: 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
Opioids consumption after hepatectomy
Time frame: Up to 48 postoperative hrs
First request of analgesia
Time frame: Up to 48 postoperative hrs
Nausea
Time frame: Up to 48 postoperative hrs
Vomiting
Time frame: Up to 48 postoperative hrs
Respiratory depression
Time frame: Up to 48 postoperative hrs
Pruritus
Time frame: Up to 48 postoperative hrs
Sedation Score
Time frame: Up to 48 postoperative hrs
Time to first off-bed activity
Time frame: Up to discharge from hospital
Lower extremity muscle strength
Time frame: Up to 48 postoperative hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 27156349Go R, Huang YY, Weyker PD, Webb CA. Truncal blocks for perioperative pain management: a review of the literature and evolving techniques. Pain Manag. 2016 Oct;6(5):455-68. doi: 10.2217/pmt-2015-0012. Epub 2016 May 9.
- Background: PubMed 27891579Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.
- Background: PubMed 27315184El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus Lumborum Block Nomenclature and Anatomical Considerations. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):548-9. doi: 10.1097/AAP.0000000000000411. No abstract available.
- Background: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Background: PubMed 26735154Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
- Background: PubMed 27939905Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. No abstract available.
- Background: PubMed 27687315Cardoso JM, Sa M, Reis H, Almeida L, Sampaio JC, Pinheiro C, Machado D. [Type II Quadratus Lumborum block for a sub-total gastrectomy in a septic patient]. Braz J Anesthesiol. 2018 Mar-Apr;68(2):186-189. doi: 10.1016/j.bjan.2016.09.009. Epub 2016 Sep 28.
- Background: PubMed 26174113Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Dec;27(8):694-6. doi: 10.1016/j.jclinane.2015.05.006. Epub 2015 Jul 11. No abstract available.
- Background: PubMed 27997495La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
- Background: PubMed 27871532Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Tao, MD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block and Thoracic Paravertebral Block in people with Quadratus Lumborum Block and Thoracic Paravertebral Block, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junyun Fan, Bachelor (0086-15920091179 ext. 86-020-627864, 381774142@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: From 1 day before the surgery to the 2 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540537, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.