Lower Thoracic Epidural vs Erector Spinae Block for PNL

Lower Thoracic Epidural Versus Erector Spinae Block for Postoperative Analgesia for Percutaneous Nephrolithotomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Procedure: Lower thoracic epidural; Procedure: Erector spinae plane block

Detailed Description

Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with multiple or complex kidney or upper urinary tract stones, which necessitates the meticulous multi-modality analgesia due to mild to moderate pain originated from renal capsule dilation or nephrostomy-tube-related stress during the first 24 h after operation.

The main sources of the acute pain after PCNL are visceral pain originating from the kidneys and ureters, and somatic pain from the site incision. Renal pain is conducted through T10-L1 spinal nerves while ureter pain is conducted through T10-L2. Moreover, cutaneous innervation of the site of the incision is predominantly supplied by T10-T11 (T8-T12) because the incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space, or in the subcostal area Blockade of both somatic and visceral nerves that innervate skin, muscle, kidneys, and ureters is required for the achievement of adequate analgesia after PCNL. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as Lower Thoracic Epidural , Thoracic paravertebral block, Transversus abdominis block, Erector spinae block, and peri-tubal local anaesthetic infiltration .

PCNL surgery also has an increased risk for postoperative pulmonary complications because the procedure is performed near the diaphragm, especially, when approached through the upper pole of the kidney which increases the possibility of pleural and lung injuries. with poor control of the postoperative pain, this can result in decreased inspiratory and vital capacities and increase the incidence of lung atelectasis and postoperative hypoxemia. Multimodal analgesia techniques are utilized broadly to manage postoperative pain. The concept of multimodal analgesia implies not only providing analgesic drugs, but also performing nerve blocks with local anaesthetics.

Since Forrero et al. first described the Erector Spinae Plane Block (ESPB), the indications and clinical use of the block for different surgical interventions have been growing . Although, ESPB is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may derive from spread to the paravertebral and epidural space. Regional anesthesia may reduce the rate of chronic pain after surgery . Thoracic epidural blockade (TEB) using local anesthetic agents has been widely regarded as the gold standard for analgesia and reduction of associated complications following surgery.

Epidural analgesia was first accomplished by blockage with local anesthetics, and bupivacaine has been called the local anesthetic of choice for epidural infusion.. Epidural local anesthetics have been administered by continuous infusion in an attempt to minimize side effects , Nevertheless, hypotension as well as motor block , numbness , nausea and urinary retention have occurred.

Good analgesia from an epidural block can result in relieving postoperative pain , early extubation, better ventilatory mechanics and gas exchange and reduced rates of lung collapse, pneumonia and pain . However, the technique requires highly trained medical staff not only for insertion and removal of the epidural catheter but also for the management of the continuous infusion of pain medication. The risks associated with insertion of the epidural include accidental dural puncture, inadvertent high block, local anesthetic toxicity and total spinal anesthesia (inadvertent spinal injection of an epidural dose of local anesthetic), nerve injury, epidural hematoma and abscess are rare but serious complications.

Epidural is not a suitable technique for all patients and is contraindicated in patients with local infection, previous spinal surgery, disorders of blood clotting and in those taking anti-coagulant and anti-platelet therapy .

Thus, in the current study the investigators aim to compare the post-operative analgesic effect of Lower Thoracic Epidural with that of ESPB after Percutaneous Nephrolithotomy.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: keroles Heshmat Ghaly, MBBS; Phone Number: 01271655519; Email: kero.heshoo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower thoracic epiduarl; 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; 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.
Experimental: Erector spinae block; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Total opioid used	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First analgesic request	When the patient first time need analgesia	48 hours postoperatively
Pain scores	Numerical rating scale	48 hours postoperatively
Analgesic drug consumption other than Nalbuphine	Another drug needed and it's consumption	48 hours postoperatively
Ambulation Time	The time the patient first ambulated following the surgical procedure	48 hours postoperatively
Patient satisfaction with anathesia	If the patient feels pain using Visual Analogue Scale	48 hours postoperativelyi
Heart rate in beats per minute	Heart rate be stable during operation	Intraoperatively
Mean arterial pressure in mmHg	Be stable during operation	Intraoperatively
Incidence of postoperative nausea and vomiting	If the patient feels vomiting and nausea and when	48 hours
Block related complication	If there is any complications as local anesthetic toxicity , pneumothorax and vascular puncture during block procedure	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed Mohamed Abd EL Latif, Professor, Assuit University Hospital; Study Director: Amr Mohamed Ahmed Thabet, Lecturer, Assuit University Hospital

Publications and helpful links

Helpful Links

• The Effect of Local Anesthetic Infiltration Around Nephrostomy Tract on Postoperative Pain Control after Percutaneous Nephrolithotomy.
• 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 record dates

Study Major Dates

• Study Start (Estimated): January 11, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Erector spinae block; Lower thoracic epidural; Postoperative analgesia for PCNL
• Other Study ID Numbers: Epidural vs ESPB in PCNL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No