Ultrasound Guided Erector Spinae Block Versus Thoracic Para-vertebral Block Versus Quadratus Lamborum Block in Open Renal Surgeries

Sponsor

mohamed A Aboelsuod, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05890248

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open renal surgeries are associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or by systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension, headache, nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting , constipation , allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank (T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic.

PVB is effective for pain relief in the thoracic, abdominal and limb regions. primary aim was to compare postoperative opioid consumption rates at 24 h. Secondary end points were to compare pain scores and hemodynamic variables.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease	Procedure: Technique

Detailed Description

This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to January 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups

Study Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Ultrasound Guided Erector Spinae Block Versus Thoracic Para-vertebral Block Versus Quadratus Lamborum Block in Open Renal Surgeries

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Erector spinea block -ESPB Group (n=12): Received erector spinae plane block.	Procedure: Technique Paravertebral block versus Erector spinea block versus quadratus lamborum block Other Names: Paravertebral block versus Erector spinea block versus quadratus lamborum block
Thoracic Paravertebral block TPVB Group (n=12) : Received thoracic paravertebral block.	Procedure: Technique Paravertebral block versus Erector spinea block versus quadratus lamborum block Other Names: Paravertebral block versus Erector spinea block versus quadratus lamborum block
Control group Control Group (n=12): Received morphine (0.1 mg/kg iv) before skin incision .
QLB group Quadratus lamborum block n=12	Procedure: Technique Paravertebral block versus Erector spinea block versus quadratus lamborum block Other Names: Paravertebral block versus Erector spinea block versus quadratus lamborum block

Outcome Measures

Primary Outcome Measures

Total morphine requirements 24 hours postoperatively [24 hours post operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion criteria: Adult patients of both sex, (21-65 years) with renal surgeries with ASA I , II score.

Exclusion criteria

Patient's refusal.
Patients with ASA (III , IV) score.
Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )
Infection at the injection site.
Allergy to local anesthetics.
Patients receiving opioids for chronic analgesic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azhar University	Cairo		Egypt	11765

Sponsors and Collaborators

mohamed A Aboelsuod, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohamed A Aboelsuod, MD, assisstant professor, Azhar University

ClinicalTrials.gov Identifier:

NCT05890248

Other Study ID Numbers:

Mohamed A Aboelsuod

First Posted:

Jun 6, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Study Results

No Results Posted as of Jun 8, 2023