Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy

NCT04650737 | Unknown

• 1 other identifier: ESPB in nephrolithotomy
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study is designed to assess the efficacy of a single shot ESPB with Dexmedetomidineversus continuous ESPB in perioperative analgesia for PCNL. Both techniques are conducted for patients undergoing PCNL under GA.

Conditions

Stone, Kidney

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative Analgesia:

  "the time interval between extubation and the first request to postoperative analgesia

  post-operative period(24 hours)

Secondary Outcomes (2)

• Duration of sensory block

  24 hours

• Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement

  24 hours

Study Arms (2)

Group A (single shot,n=20)

ACTIVE COMPARATOR

Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB

Drug: single shot ESBP with dexmedtomidine

Group B (continous infusion,n=20)

ACTIVE COMPARATOR

Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs;ESPB

Drug: continous ESPB

Interventions

single shot ESBP with dexmedtomidine DRUG

Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine

Group A (single shot,n=20)

continous ESPB DRUG

Patients in this group will receive erector spine plane block with 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs.

Group B (continous infusion,n=20)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy

You may not qualify if:

• \- Body mass index greater than 35 kg/m2.
• Pregnancy.
• Unstable coronary artery disease, congestive heart failure, or arrhythmias.
• Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
• Pre-existing neurological deficits or neuropathy.
• Significant psychiatric or cognitive conditions interfering with consent or assessment.
• Significant renal impairment (creatinine above 2 mg/dl)
• Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
• Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
• Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.

  PMID: 29885165 BACKGROUND

• Schug SA, Fry RA. Continuous regional analgesia in comparison with intravenous opioid administration for routine postoperative pain control. Anaesthesia. 1994 Jun;49(6):528-32. doi: 10.1111/j.1365-2044.1994.tb03528.x.

  PMID: 8017600 BACKGROUND

• Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.

  PMID: 29288788 BACKGROUND

• Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.

  PMID: 19602964 BACKGROUND

• Farag E, Argalious M, Abd-Elsayed A, Ebrahim Z, Doyle DJ. The use of dexmedetomidine in anesthesia and intensive care: a review. Curr Pharm Des. 2012;18(38):6257-65. doi: 10.2174/138161212803832272.

  PMID: 22762468 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Both groups will receive Ultrasound guided ESPB before induction of general anesthesia * Single shot group (A):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine. * Continous infusion group (B):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 29, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share