AzTrials
AzTrials

Developmental Dysplasia of the Hip (DDH)NCT03189966

Truncal Blocks for Pediatric With Developmental Dysplasia of the Hip Undergoing Open Reduction

A study testing transversalis fascia plane block and quadratus lumborum block in people with Developmental Dysplasia of the Hip (DDH), run by Second Affiliated Hospital of Wenzhou Medical University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study is to evaluate the effectiveness of ultrasound-guided transversalis fascia plane block (TFPB) and quadratus lumborum block (QLB) on post-operative analgesia in pediatric patients with Developmental Dysplasia of the Hip (DDH)under going open reduction surgeries(Salter acetabular osteotomy,combined… Read more about this study

Who is it for?
Ages 2 to 10 years
Conditions the study is for
Developmental Dysplasia of the Hip (DDH)
What is being tested?
transversalis fascia plane block and quadratus lumborum block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesChina
Study dates
10 Aug 2017to 1 Jul 2018
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 2 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Pediatric patients aged between 2 years and 10 years with DDH,
  • scheduled for unilateral open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy)

Who cannot join

  • Patients will be excluded if they meet any of the following criteria:
  • patients with known allergy to local anaesthetics,
  • mental disability,
  • peripheral neuropathy,
  • a coagulopathy disorder,
  • localized infection in the area,
  • any reason cause reoperation.

Trial locations and contacts

2 sites in 1 country.

China2 sites
  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100000

  • Second Affiliated Hospital of WenZhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: Effect of Different Truncal Blocks Under Ultrasound-Guidance on Pain Management After Open Reduction of Pediatric Developmental Dysplasia of the Hip: a Randomized Trial

The aim of the study is to evaluate the effectiveness of ultrasound-guided transversalis fascia plane block (TFPB) and quadratus lumborum block (QLB) on post-operative analgesia in pediatric patients with Developmental Dysplasia of the Hip (DDH)under going open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy).The effectiveness of TFPB/QLB for perioperative analgesia in lumbar nerves (L1) innervated surgery have been demonstrated in recent studies. However, this regional technique rarely applied to children.The objective of our research is to assess the quality of postoperative analgesia in pediatric patients who had received a preoperative TFPB/QLB for hip surgery.

Read the detailed description

90 pediatric patients(age 2-10years) in the BeiJing Ji Shui Tan Hospital and The Second Affiliated Hospital of Wen Zhou Medical University with American Society of Anesthesiologists (ASA) physical status I or II, who are scheduled to undergo open reduction surgeries (Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy)are selected and divided into 3 equal groups with 30 subjects.The consent forms are approved by the institutional Ethics Committee.

Inclusion Criteria: Pediatric patients between 2 years to 10 years with DDH, scheduled for unilateral open reduction surgeries(Salter acetabular osteotomy,combined with proximal femoral rotation osteotomy).

Exclusion Criteria:Patients will be excluded if participants meet any of the following criteria:patients with known allergy to local anaesthetics, mental disability, peripheral neuropathy, a coagulopathy disorder,localized infection in the area, and any reason cause reoperation.

Electrocardiogram, non-invasive blood pressure, pulse oximetry, temperature,capnography, and end tidal anesthetic concentration values are monitored in patients Parental presence will be allowed if requested for the induction of anesthesia. Pediatrics without vein access will receive general anesthesia which induces with 8% sevoflurane in 70% nitrous oxide and 30% oxygen, via a facemask. When loss of consciousness is achieved,investigators need to establish vein access routinely.Intravenous induction for general anesthesia with endotracheal intubation is commenced using intravenous propofol 3 mg/kg, cis-atracurium 0.2 mg/kg,fentanyl 2. ug/kg. Anesthesia will be maintained using remifentanyl, and a volatile anesthetic(sevoflurane). The inhaled concentration of sevoflurane will be adjusted to maintain hemodynamic stability, which is defined as a change in systolic blood pressure and heart rate of no more than 20% of baseline parameters. The use of opioids during the perioperative periods at the discretion of the anesthetist. Some anesthetists administer opioids preemptively, however, in the majority of cases the decision is based on the cardiovascular response to stimulation; an increase in heart rate of 10% from baseline is usually interpreted as insufficient analgesia and is treated with opioids. Patients will be given either fentanyl in doses of 1-2mcg/kg, remifentanil as continuous infusion 0.01-0.03 mcg/ (kg.min) or a combination of these.

TFPB group Patients in transversalis fascia plane block group(Group T) will receive ultrasound-guided transversalis fascia plane block using0.3% ropivacaine(0.8 ml/kg) after general anesthesia. A high-frequency probe (Sono-Site HFL50x, 15- 6 MHz, 55-mm broadband linear array) connected to an S-nerve ultrasound machine((Sonosite Inc,Bothell, WA, USA) was positioned with a transverse orientation, between iliac crest and costal margin.With the patient in a supine position, the needle is advanced from the anterior using an in-plane technique. A linear ultrasound probe is orientated transversely over the lateral abdomen between the iliac crest and the costal margin. The external oblique, internal oblique,and transversus abdominis muscles are imaged, and the more posterior transversus aponeurosis is isolated from these muscles.The reflection of the peritoneum curving away from the muscles from anterior to posterior, and the perinephric fat, which lies behind the peritoneum and deep to the transversalis fascia, are both identified. The perinephric fat is generally more prominent closer to the iliac crest. The quadratus lumborum is identified medial to the aponeurosis of the transversus abdominis. The end point is more visible if the needle is passed through the posterior''tail'' of the transversus muscle, as the transversus aponeurosis is thinner and less distinct as a separate layer. After passing through the deep surface of transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the anterior border of QLM and its fascia, in addition to a minimal anterior spread in TAP plane. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.

QLB group Patients in quadratus lumborum block group(Group Q) will receive ultrasound-guided quadratus lumborum block using 0.3% ropivacaine(0.8 ml/kg).after general anesthesia.The TFPB is performed with the patient in the lateral position using a curvilinear low-frequency ultrasound probe.This is orientated transversely at the posterior axillary line between the iliac crest and the costal margin using a 22G 100-mm needle.The needle is directed in the posterior to anterior orientation with the practitioner standing behind the patient. The triangular quadratus lumborum (QL) muscle is adherent to the apex of the transverse process of L3 vertebra.Using the Shamrock method, a new transmuscular quadrates lumborum block technique, developed by Børglum (British Journal of Anaesthesia, 2013), the needle penetrates the QL muscle with an in-plane approach from the posterior side of the ultrasound probe. The target point is the interfascial plane between the QL and the psoas major muscle just deep to the transversalis fascia, in order to lessen the risk of unintentional penetration of the peritoneal cavity contrary to the technique. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading antero-posteriorly between the QL and the psoas major muscle. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.

Control group Patients in the third group as control (Group C) receive no nerve block.Patients will be extubated based on clinical criteria.

Patients will then be transported to the post-operative anesthesia care unit (PACU) after extubation.All pediatric patients will receive 6-hourly paracetamol post-operatively for two days and receive sufentanyl via nurse-controlled analgesia (NCA) or patient-controlled analgesia (PCA). The prescription of post-operative NCA/PCA is also at the discretion of the anesthetist. Children under the age of 6 years will receive sufentanyl via NCA continuously at a rate of 2 mcg/(kg.48h) with a bolus option of 0.01 mcg/kg every 15 minutes.Older children will receive sufentanyl via PCA continuously at a rate of 2 mcg/( kg.48h) with a bolus option of 0.01 mcg/kg every 15 minutes.

Data collection will include the type of procedure, age, weight, type of truncal block (QLB group vs TFPB vs control).Primary outcome was the FLACC (ie, the Face, Legs, Activity, Consolability Scale) score of patients in the PACU and at 2h, 4h, 8h, 12h, 24h, 48h postoperatively. Secondary outcomes included intraoperative MBP and HR at the endpoints of Salter acetabular osteotomy(T1), femoral rotation osteotomy (T2), and anterior superior iliac spine osteotomy (T3) during the surgery; intraoperative opioid consumption (i.e., fentanyl and remifentanil); duration of the surgery; postoperative fentanyl consumption in the PACU, postoperative morphine consumption in the ward; the length of PACU stay; the time until first press of NCA/PCA pump and the total counts number of pressing the pump; length of hospital stay; complications (e.g., immediate complications such as vessel puncture and possible undesirable effects such as hypotension, bradycardia, epidural local anesthetic spread, or postoperative nausea and vomiting). The number of doses of rescue analgesics (morphine 0.05 mg/kg) in the postoperative period (48 h) will be recorded. Rescue treatment of postoperative nausea and vomiting,will be treated with ondansetron (0.1 mg/kg) if needed.Side effects such as pruritus will also be noted.

Being tested
transversalis fascia plane block, quadratus lumborum block
Keywords
transversalis fascia plane block, quadratus lumborum block, ultrasound-guided, Developmental Dysplasia of the Hip, postoperative analgesia
Medical subject headings
Developmental Dysplasia of the Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transversalis fascia plane blockProcedure or surgery

    With the patient in a supine position, the needle is advanced from the anterior using an in-plane technique. A linear ultrasound probe is orientated transversely over the lateral abdomen between the iliac crest and the costal margin. Local anesthetic is injected to separate the transversalis fascia from the transversus muscle. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the anterior border of QLM and its fascia, in addition to a minimal anterior spread in TAP plane. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.

  • quadratus lumborum blockProcedure or surgery

    The needle is directed in the posterior to anterior orientation with the practitioner standing behind the patient. The triangular quadratus lumborum (QL) muscle is adherent to the apex of the transverse process of L3 vertebra. Using the Shamrock method, the needle penetrates the QL muscle with an in-plane approach from the posterior side of the ultrasound probe. The target point is the inter fascial plane between the QL and the psoas major muscle just deep to the transversalis fascia, in order to lessen the risk of unintentional penetration of the peritoneal cavity contrary to the technique. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the QL and the psoas major muscle. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.

Study groups in NCT03189966
Study groupRoleWhat they receive
Group TExperimentalPatients in transversalis fascia plane block group(Group T) will receive ultrasound-guided transversalis fascia plane block using0.3% ropivacaine(0.8 ml/kg) after general anesthesia
Receives: Procedure: transversalis fascia plane block
Group QExperimentalPatients in quadratus lumborum block group(Group Q) will receive ultrasound-guided quadratus lumborum block using0.3%ropivacaine(0.8 ml/kg).after general anesthesia.
Receives: Procedure: quadratus lumborum block
Group CNo interventionPatients in the third group as control (Group C)receive no nerve block.Patients will be extubated based on clinical criteria.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of FLACC pain scores at different time points (at rest and at movement)

    using age-appropriate and validated tools (ie, the Face, Legs, Activity, Consolability Scale [FLACC] which evaluates the intensity of pain, ranged from 0-10, 0 means no pain and 10 means severe pain) to evaluate the change of pain scores at different time points which indirectly reflect the analgesia effect, both at rest and at movement.

    Measured: for the first 48 post-operative hours(at PACU, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours after surgery),the analgesic effects of patients at different times need to be evaluated, both at rest and at movement

Secondary outcomes (9)
  1. The analgesia effects

    The first time (hours after surgery) and the total numbers to press the analgesia pump (numbers) will be recorded.

    Measured: for the first 48 post-operative hours

  2. the rescue analgesics

    The number of doses of rescue analgesics (morphine 0.05 mg/kg) will be recorded.

    Measured: for the first 48 post-operative hours

  3. complications

    Postoperative nausea and vomiting (the numbers of participants with nausea and vomiting), hematoma (the number of participants with hematoma), nerve injury (the number of participants with nerve injury) will be recorded

    Measured: for the first 48 post-operative hours

  4. Intra-operative opioid consumptions

    intraoperative opioid consumption ((both fentanyl and remifentanil were converted into fentanyl equivalents).

    Measured: during the surgery, average 3 hours

  5. PACU fentanyl consumptions

    If a pain score was >3, the patient in the PACU would receive fentanyl (iv,1 μg·kg-1), while in the surgical ward morphine (iv,0.05 mg·kg-1) was administered.

    Measured: the time of staying in postanesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery

  6. PACU fentanyl rate

    the number of patients who received the fentanyl in each group during the PACU

    Measured: the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery

  7. PACU stay

    staying period in the PACU

    Measured: the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery

  8. Hospital stay

    staying period in the hospital

    Measured: the time of staying in hospital, average 12 days

  9. Parental satisfaction score (0-10)

    Satisfaction from all patients' guardians were surveyed with regard to the postoperative analgesia of their children at the time of the NCA/PCA pump removal

    Measured: at 48 post-operative hours, when removed the NCA/PCA pump

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start10 Aug 2017
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03189966
Sponsor's protocol ID
18
Status last verified
Mar 2021
First submitted
26 Apr 2017
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22.

    PubMed 27185672
  • Parras 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
  • Chin KJ, Chan V, Hebbard P, Tan JS, Harris M, Factor D. Ultrasound-guided transversalis fascia plane block provides analgesia for anterior iliac crest bone graft harvesting. Can J Anaesth. 2012 Jan;59(1):122-3. doi: 10.1007/s12630-011-9610-7. Epub 2011 Oct 19. No abstract available.

    PubMed 22009659
  • Lee S, Goetz T, Gharapetian A. Unanticipated Motor Weakness with Ultrasound-Guided Transversalis Fascia Plane Block. A A Case Rep. 2015 Oct 1;5(7):124-5. doi: 10.1213/XAA.0000000000000237.

    PubMed 26402025
  • Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

    PubMed 18428988
  • Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.

    PubMed 22286518
  • Sakamoto H, Akita K, Sato T. An anatomical analysis of the relationships between the intercostal nerves and the thoracic and abdominal muscles in man. I. Ramification of the intercostal nerves. Acta Anat (Basel). 1996;156(2):132-42. doi: 10.1159/000147838.

    PubMed 8993633
  • JAMIESON RW, SWIGART LL, ANSON BJ. Points of parietal perforation of the ilioinguinal and iliohypogastric nerves in relation to optimal sites for local anaesthesia. Q Bull Northwest Univ Med Sch. 1952;26(1):22-6. No abstract available.

    PubMed 14912259
  • Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

    PubMed 18020088
  • Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.

    PubMed 26771297
  • Dam M, Hansen CK, Borglum J, Chan V, Bendtsen TF. A transverse oblique approach to the transmuscular Quadratus Lumborum block. Anaesthesia. 2016 May;71(5):603-4. doi: 10.1111/anae.13453. No abstract available.

    PubMed 27072772
  • Blanco 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 26225500
  • Elsharkawy H. Quadratus lumborum block with paramedian sagittal oblique (subcostal) approach. Anaesthesia. 2016 Feb;71(2):241-2. doi: 10.1111/anae.13371. No abstract available.

    PubMed 26750418
  • McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

    PubMed 17961838
  • Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

    PubMed 21851346

Questions about this trial

What is this clinical trial studying?

A study testing transversalis fascia plane block and quadratus lumborum block in people with Developmental Dysplasia of the Hip (DDH), run by Second Affiliated Hospital of Wenzhou Medical University at 2 sites 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of FLACC pain scores at different time points (at rest and at movement) (time frame: for the first 48 post-operative hours(at PACU, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours after surgery),the analgesic effects of patients at different times need to be evaluated, both at rest and at movement). 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 NCT03189966, which also lists 27 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 19 Mar 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in