MedDataX Logo

Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy

NCT ID: NCT05448469

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-10

Study Completion Date

2022-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

general anesthesia+ bilateral US guided erector spinae plane block

General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9

Group Type ACTIVE_COMPARATOR

ultrasound guided erector spinae plane block

Intervention Type PROCEDURE

patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.

general anesthesia+ bilateral US guided paravertebral block

General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10

Group Type ACTIVE_COMPARATOR

ultrasound guided paravertebral block

Intervention Type PROCEDURE

patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.

general anesthesia

general anesthesia plus conventional analgesia

Group Type ACTIVE_COMPARATOR

conventional analgesia

Intervention Type DRUG

patients will receive combined general anesthesia and conventional analgesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasound guided erector spinae plane block

patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.

Intervention Type PROCEDURE

ultrasound guided paravertebral block

patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.

Intervention Type PROCEDURE

conventional analgesia

patients will receive combined general anesthesia and conventional analgesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
* physical status American Society of Anesthesiologists (ASA) II or III.

Exclusion Criteria

* Patients who refuse to participate
* patients with body mass index (BMI) \>35 kg/m2
* infection at the site of injection
* coagulopathy, severe thrombocytopenia \<50×103
* spine deformity
* history of opioid dependence
* polytrauma patients with dorsal spine fracture
* urgent abdominal exploration for splenectomy in heamodynamically unstable patients
* history of allergy to opioids or local anesthetics
* history of allergy to opioids, or local anaesthetics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R 97/2022

Identifier Type: -

Identifier Source: org_study_id