Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Active comparator
  Conventional caudal block

  Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block

  Procedure: Conventional caudal block

• Experimental
  Ultrasound-guided caudal block

  Patients of this group will receive caudal block using ultrasound.

  Procedure: Ultrasound-guided caudal block

• Experimental
  Ultrasound guided erector spinae plane Block

  Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) .

  Procedure: Ultrasound guided erector spinae plane Block

Interventions

• ProcedureConventional caudal block

  Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).

• ProcedureUltrasound-guided caudal block

  Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).

• ProcedureUltrasound guided erector spinae plane Block

  Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

Primary outcomes

1. Degree of pain intensity

   To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)

   Time frame: First 24 hours postoperative

Secondary outcomes

1. Changes in mean arterial blood pressure

   Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).

   Time frame: Intraoperative and first 24 hours postoperative

2. Changes in heart rate

   Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).

   Time frame: Intraoperative and first 24 hours postoperative

3. Amount of Analgesic required in the first day after surgery

   The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score \> 4.

   Time frame: First 24 hours postoperative

4. Time to first rescue analgesic demand after surgery.

   measured from the end of surgery till patient require analgesia.

   Time frame: First 24 hours postoperative

5. Success rate of block

   a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not\>20% of the basal levels. If the increase is\>20%, the block is accepted as unsuccessful.

   Time frame: Intraoperative duration

6. Duration of performing the block

   Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration

   Time frame: Intraoperative duration

7. Incidence of complications

   Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST).

   Time frame: Intraoperative and first 24 hours postoperative

Individual participant data

Plan to share: Yes — Data will be available upon reasonable request

Supporting information: Study protocol, Sap