NCT05890248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 14, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine requirements 24 hours postoperatively

    24 hours post operative

Study Arms (4)

Erector spinea block

-ESPB Group (n=12): Received erector spinae plane block.

Procedure: Technique

Thoracic Paravertebral block

TPVB Group (n=12) : Received thoracic paravertebral block.

Procedure: Technique

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

Interventions

TechniquePROCEDURE

Paravertebral block versus Erector spinea block versus quadratus lamborum block

Also known as: Paravertebral block versus Erector spinea block versus quadratus lamborum block
Erector spinea blockQLB groupThoracic Paravertebral block

Eligibility Criteria

Age21 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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 September 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar University

Cairo, 11765, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

May 14, 2023

First Posted

June 6, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations