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

March 16, 2021 updated by: congcong huang, Second Affiliated Hospital of Wenzhou Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

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 Locations

  • China
    • Beijing
      • BeiJing, Beijing, China, 100000
        • Beijing Jishuitan Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Second Affiliated Hospital of Wenzhou Medical University

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

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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）

Exclusion Criteria:

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group T
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
Procedure: transversalis fascia plane block
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.
Experimental: Group Q
Patients in quadratus lumborum block group（Group Q） will receive ultrasound-guided quadratus lumborum block using0.3%ropivacaine(0.8 ml/kg).after general anesthesia.
Procedure: quadratus lumborum block
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.
No Intervention: Group C
Patients in the third group as control (Group C)receive no nerve block.Patients will be extubated based on clinical criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The analgesia effects
Time Frame: for the first 48 post-operative hours
The first time (hours after surgery) and the total numbers to press the analgesia pump (numbers) will be recorded.
for the first 48 post-operative hours
the rescue analgesics
Time Frame: for the first 48 post-operative hours
The number of doses of rescue analgesics (morphine 0.05 mg/kg) will be recorded.
for the first 48 post-operative hours
complications
Time Frame: for the first 48 post-operative hours
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
for the first 48 post-operative hours
Intra-operative opioid consumptions
Time Frame: during the surgery, average 3 hours
intraoperative opioid consumption ((both fentanyl and remifentanil were converted into fentanyl equivalents).
during the surgery, average 3 hours
PACU fentanyl consumptions
Time Frame: the time of staying in postanesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
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.
the time of staying in postanesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
PACU fentanyl rate
Time Frame: the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
the number of patients who received the fentanyl in each group during the PACU
the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
PACU stay
Time Frame: the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
staying period in the PACU
the time of staying in post-anesthesia care unit(PACU), about 30 minutes to 60 minutes after surgery
Hospital stay
Time Frame: the time of staying in hospital, average 12 days
staying period in the hospital
the time of staying in hospital, average 12 days
Parental satisfaction score (0-10)
Time Frame: at 48 post-operative hours, when removed the NCA/PCA pump
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
at 48 post-operative hours, when removed the NCA/PCA pump

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborators

Beijing Jishuitan Hospital

Investigators

  • Principal Investigator: CongCong Huang, Master, Second Affiliated Hospital of Wenzhou 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

Helpful Links

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)

August 10, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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