ESP Block for Laparoscopic Nephrectomy Surgeries

NCT04085237 | Terminated

• 1 other identifier: 7119
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Most laparoscopic surgeries are performed through 3 to 4 small (1 to 1.5 cm) incisions; however, laparoscopic nephrectomies for cancer include one of the incisions being extended to 7 to 10 cm for kidney removal. Although pain after laparoscopic surgery is somewhat less than that after open surgery, it is still significant, and opioid consumption is similar. Opioids have been a mainstay for the treatment of post-operative pain, but they are associated with many adverse effects and a potential for long-term use. Thus, combining opioid analgesia with other forms of analgesia has the potential to reduce opioid use. Paravertebral nerve blocks, where local anesthetic is injected near the spinal nerves, have recently shown good pain control in patients undergoing thoracic and abdominal surgeries. However, this technique is technically challenging, time consuming, and has the risk of significant side effects. Fascial plane blocks are an alternative to paravertebral blocks. Fascial plane blocks, where local anesthetic is injected in areas further away from the spinal nerves, are easier to perform than paravertebral blocks, and have fewer associated risks. A recently described fascial plane block, the Erector Spinae Plane (ESP) block, has been shown to be effective in controlling pain in a variety of surgeries. However, currently, there is little information regarding its use in laparoscopic nephrectomy. We are proposing this pilot randomized control trial to look at the feasibility of completing a larger randomized control trial to evaluate ESP blockade in patients undergoing laparoscopic nephrectomy for cancer. We will also investigate total opioid consumption, and pain scores at rest and during movement.

Conditions

Kidney Cancer; Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up

  Number of patients recruited per week

  One week

Secondary Outcomes (3)

• Opioid Consumption

  48 hours

• Pain scores at rest and movement

  Day 1

• Number of Adverse Events

  Day 1-2

Study Arms (2)

Ultrasound-guided continuous ESP block with opioid PCA

EXPERIMENTAL

A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. The patient's skin will be anesthetized with 2% lidocaine. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg) followed by insertion of the echo catheter system under direct vision 2-3 cm beyond the needle tip.

Drug: Ropivacaine injection

Ultrasound-guided sham block and catheter with opioid PCA

SHAM COMPARATOR

The exact same procedure as the experimental group will be followed, substituting saline for local anesthetic at the same amounts and rate. As with the ESP group, the patients will have PCA initiated postoperatively in the PACU at the same doses.

Other: Sham

Interventions

Ropivacaine injection DRUG

30ml of 0.375% ropivacaine with 5mcg/ml of epinephrine will be injected into the fascial plane on the anterior spinae muscle.

Also known as: Naropin

Ultrasound-guided continuous ESP block with opioid PCA

Sham OTHER

Saline will be used at the same amounts as the ropivacaine arm.

Also known as: Placebo

Ultrasound-guided sham block and catheter with opioid PCA

Eligibility Criteria

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

You may qualify if:

• Patients requiring laparoscopic nephrectomy and partial nephrectomy for malignancy
• Patients of age 18 and over
• BMI \< 40
• Patients who are expected to stay in-hospital overnight after surgery

You may not qualify if:

• Patient refusal
• Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
• Known allergy to local anesthetics
• Inability to provide informed consent
• Inability to use a PCA due to languate or comprehension barriers
• BMI \>= 40
• Any patient on opioids for greater than or equal to 3 months duration prior to surgery
• Patients with chronic pain syndromes
• Donor nephrectomies due to incision location
• Cystic kidney because of very large incisions

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (3)

• Alper I, Yuksel E. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial. Medicine (Baltimore). 2016 Apr;95(16):e3433. doi: 10.1097/MD.0000000000003433.

  PMID: 27100439 RESULT

• Shah A, Rowlands M, Krishnan N, Patel A, Ott-Young A. Thoracic Intercostal Nerve Blocks Reduce Opioid Consumption and Length of Stay in Patients Undergoing Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2015 Nov;136(5):584e-591e. doi: 10.1097/PRS.0000000000001717.

  PMID: 26505714 RESULT

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Pain, Postoperative

Interventions

Ropivacaine; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Shahid Lambe, MD

  St. Joseph's Healthcare Hamilton and McMaster University

  PRINCIPAL INVESTIGATOR

• Peter Moisiuk, MD

  St. Joseph's Healthcare Hamilton and McMaster University

  PRINCIPAL INVESTIGATOR

• Aaron Kugler, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research Pharmacy will provide randomization/allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility pilot study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: January 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: October 16, 2023
• Last Updated: June 4, 2026

Record last verified: 2024-02

Locations

CA (1)