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

NCT03189966 | Completed

• 1 other identifier: 18
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

transversalis fascia plane block; quadratus lumborum block; ultrasound-guided; Developmental Dysplasia of the Hip; postoperative analgesia

Outcome Measures

Primary Outcomes (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.

  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)

• The analgesia effects

  for the first 48 post-operative hours

• the rescue analgesics

  for the first 48 post-operative hours

• complications

  for the first 48 post-operative hours

• Intra-operative opioid consumptions

  during the surgery, average 3 hours

• PACU fentanyl consumptions

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

Study Arms (3)

Group T

EXPERIMENTAL

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

Group Q

EXPERIMENTAL

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

Group C

NO INTERVENTION

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

Interventions

transversalis fascia plane block PROCEDURE

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.

Group T

quadratus lumborum block PROCEDURE

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.

Group Q

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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）

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (2)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100000, China

Location

Second Affiliated Hospital of WenZhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (27)

• 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.

  PMID: 27185672 BACKGROUND

• 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.

  PMID: 26302669 BACKGROUND

• 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.

  PMID: 22009659 BACKGROUND

• 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.

  PMID: 26402025 BACKGROUND

• 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.

  PMID: 18428988 BACKGROUND

• 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.

  PMID: 22286518 BACKGROUND

• 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.

  PMID: 8993633 BACKGROUND

• 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.

  PMID: 14912259 BACKGROUND

• 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.

  PMID: 18020088 BACKGROUND

• 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.

  PMID: 26771297 BACKGROUND

• 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.

  PMID: 27072772 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

• 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.

  PMID: 26750418 BACKGROUND

• 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.

  PMID: 17961838 BACKGROUND

• 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.

  PMID: 21851346 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• Kadam 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.

  PMID: 24249997 BACKGROUND

• Barrington MJ, Ivanusic JJ, Rozen WM, Hebbard P. Spread of injectate after ultrasound-guided subcostal transversus abdominis plane block: a cadaveric study. Anaesthesia. 2009 Jul;64(7):745-50. doi: 10.1111/j.1365-2044.2009.05933.x.

  PMID: 19624629 BACKGROUND

• Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.

  PMID: 19495909 BACKGROUND

• Rosario DJ, Jacob S, Luntley J, Skinner PP, Raftery AT. Mechanism of femoral nerve palsy complicating percutaneous ilioinguinal field block. Br J Anaesth. 1997 Mar;78(3):314-6. doi: 10.1093/bja/78.3.314.

  PMID: 9135313 BACKGROUND

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

  PMID: 22227789 BACKGROUND

• Lancaster P, Chadwick M. Liver trauma secondary to ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Apr;104(4):509-10. doi: 10.1093/bja/aeq046. No abstract available.

  PMID: 20228188 BACKGROUND

• Weikel AM, Habal MB. Meralgia paresthetica: a complication of iliac bone procurement. Plast Reconstr Surg. 1977 Oct;60(4):572-4.

  PMID: 909967 BACKGROUND

• Fernyhough JC, Schimandle JJ, Weigel MC, Edwards CC, Levine AM. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine (Phila Pa 1976). 1992 Dec;17(12):1474-80. doi: 10.1097/00007632-199212000-00006.

  PMID: 1471005 BACKGROUND

• Smith SE, DeLee JC, Ramamurthy S. Ilioinguinal neuralgia following iliac bone-grafting. Report of two cases and review of the literature. J Bone Joint Surg Am. 1984 Oct;66(8):1306-8. No abstract available.

  PMID: 6386820 BACKGROUND

• Lopez-Gonzalez JM, Lopez-Alvarez S, Jimenez Gomez BM, Arean Gonzalez I, Illodo Miramontes G, Padin Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. English, Spanish.

  PMID: 27067036 BACKGROUND

• Huang C, Zhang X, Dong C, Lian C, Li J, Yu L. Postoperative analgesic effects of the quadratus lumborum block III and transversalis fascia plane block in paediatric patients with developmental dysplasia of the hip undergoing open reduction surgeries: a double-blinded randomised controlled trial. BMJ Open. 2021 Feb 4;11(2):e038992. doi: 10.1136/bmjopen-2020-038992.

  PMID: 33542037 DERIVED

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• CongCong Huang, Master

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: June 16, 2017
• Study Start: August 10, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)