Lower Thoracic Epidural vs Erector Spinae Block for PNL

NCT05725083 | Unknown

• 1 other identifier: Epidural vs ESPB in PCNL
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower Thoracic Epidural and Erector spinae plane block are effective in providing post-operative analgesia.

Conditions

Percutaneous Nephrolithotomy

Keywords

Lower thoracic epidural; Erector spinae block; Postoperative analgesia for PCNL

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  Total opioid used

  48 hours postoperatively

Secondary Outcomes (9)

• First analgesic request

  48 hours postoperatively

• Pain scores

  48 hours postoperatively

• Analgesic drug consumption other than Nalbuphine

  48 hours postoperatively

• Ambulation Time

  48 hours postoperatively

• Patient satisfaction with anathesia

  48 hours postoperativelyi

Study Arms (2)

Lower thoracic epiduarl

EXPERIMENTAL

before induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs.

Procedure: Lower thoracic epidural

Erector spinae block

EXPERIMENTAL

before induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs.

Procedure: Erector spinae plane block

Interventions

Lower thoracic epidural PROCEDURE

before induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs.

Lower thoracic epiduarl

Erector spinae plane block PROCEDURE

before induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs.

Erector spinae block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
• patients with the American Society of Anesthesiologists (ASA) physical status I/II,
• Patients scheduled for elective Percutaneous Nephrolithotomy.

You may not qualify if:

• Contraindication to local anesthesia :
• Allergy to local anaesthetics , Infection at the site of injection , Coagulopathy
• Chronic pain syndromes
• Prolonged opioid medication
• Patients who received any analgesic 24 h before surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Paravertebral block for surgical anesthesia of percutaneous nephrolithotomy
• abdominal wall blocks
• Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patient
• Thoracic paravertebral block versus epidural anesthesia combined with moderate sedation for percutaneous nephrolithotomy
• Percutaneous nephrolithotomy under a multimodal analgesia regime.
• Application of TAP block in laparoscopic urologic surgery: Current status and future directions.
• Pulmonary complications following percutaneous nephrolithotomy
• Multimodal analgesia for controlling acute postoperative pain.
• The Erector Spinae Plane Block
• The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery
• Use of the ultrasound-guided erector spinae plane block in breast surgery
• Erector Spinae Plane Blocks Provide Analgesia for Breast and Axillary Surgery
• Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient
• Erector Spinae Plane Block Versus Retrolaminar Block
• A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade.
• Local anaesthetics and regional anaesthesia for preventing chronic pain after surgery
• Epidural catheter analgesia for the management of postoperative pain.
• Analgesia in thoracic surgery
• Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy
• A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy
• Efficacy of ultrasound-guided erector spinae plane block for analgesia after laparoscopic cholecystectomy

Study Officials

• Mohamed Mohamed Abd EL Latif, Professor

  Assuit University Hospital

  STUDY CHAIR

• Amr Mohamed Ahmed Thabet, Lecturer

  Assuit University Hospital

  STUDY DIRECTOR

Central Study Contacts

keroles Heshmat Ghaly, MBBS

CONTACT

01271655519; kero.heshoo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 13, 2023
• Study Start: January 11, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01