A Comparative Study Between Different Volumes During Erector Spinae Block for Pain Control

NCT04371341 | Completed

• 1 other identifier: _MD-248-2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment, rib fractures management in the emergency setting, treatment of abdominal surgical pain, hip arthroplasty , analgesic management in breast surgery,or in spinal surgery.Although ESP block successfully reduced postoperative opioid consumption in clinical reports, no studies thus have investigated the optimum volume of bupivacaine for ESP block as regard a review of the medical literature on December 27th, 2017 that searched terms in 14 articles clearly stated the volume of the bolus and the spread of the anesthetic after an injection of LA, the volume needed to cover one dermatome widely varies from 2.5 mL to 6.6 mL, with a median value of 3.4 mL. Furthermore, the maximum number of dermatomes reached by a single bolus in ESP was of 9 dermatomes after a 30 mL bolus. Thus, in this study, the investigators evaluate the effect of ESP block which will be performed by using three different volumes (2.5, 3.4 ,6.6 ml/segment) of bupivacaine with the same concentration ,technique ,site of injection and operation.

Conditions

Postoperative Pain Management

Keywords

erector spinae; -block; volume; pain

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption in milligrams in the three groups

  if NRS is 4 or more a 5 mg morphine IV with maximum dose of 10 mg every 6 hours will be given and the total consumption of these medications will be recorded.

  24 hours

Study Arms (4)

E1

EXPERIMENTAL

will receive erector spinae block with 0.25% bupivacaine volume of 2.5 ml/segment

Procedure: erector spinae block by 0.25% bupivacaine

E2

EXPERIMENTAL

will receive erector spinae block 0.25% bupivacaine with volume of 3.4ml/segment

Procedure: erector spinae block by 0.25% bupivacaine

E3

EXPERIMENTAL

will erector spinae block receive 0.25% bupivacaine with volume of 6.6 ml/segment

Procedure: erector spinae block by 0.25% bupivacaine

C

NO INTERVENTION

will not receive erector spinae block

Interventions

erector spinae block by 0.25% bupivacaine PROCEDURE

A mark will be applied on the required level (T8), the midline (spinous processes) and the injection points 3 cm from midline.While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. Using ultrasound guidance with a 6-10 MHz linear probe anatomical landmarks will be identified including the transverse process at T8 level and the three layers of muscles from posterior to anterior: trapezius-rhomboid-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, 0.25% bupivacaine is injected in increments with careful repetitive aspiration to avoid intravascular injection.

Also known as: erector spinae plane block

E1; E2; E3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged 18-50 years with ASA I-II undergoing open simple nephrectomy operation.

You may not qualify if:

• Cardiovascular disease.
• Cerebrovascular insufficiency.
• Coagulation defects.
• hepatic insufficiency.
• Hypersensitivity to the study drugs.
• Pregnant patient. And patients receiving vasoactive drugs or beta blockers.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

anesthesia department at Cairo University

Cairo, Elmanial, 11562, Egypt

Location

Related Publications (1)

• 1. 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 ;41(5):621-7. 2. Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth 2017;118(3):474-5 3. Josh Luftig P, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. The authors reply to the optimal dose and volume of local anesthetic for erector spinae plane blockade for posterior rib fractures. Am J Emerg Med 2018;36(6):1103-4 4. Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia 2017;7(4):452-60 5. Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth 2018;47:5-6

  BACKGROUND

MeSH Terms

Conditions

Bites and Stings; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heba Omar, M.D.

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: the care provider and investigator will be masked from the volume injected
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 4 groups with 20 patients for each group where group C will not receive erector spinae block and so will be the control group while groups which will receive erector spinae block will be E1,E2,E3 and will receive 0.25% bupivacaine with volumes of 2.5,3.4,6.6 ml/segment respectively.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: May 12, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 3, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)