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

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05448469

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: ultrasound guided erector spinae plane block Procedure: ultrasound guided paravertebral block Drug: conventional analgesia	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: general anesthesia+ US guided erector spinae plane block General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2%	Procedure: 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 %.
Active Comparator: general anesthesia+ US guided paravertebral block General anesthesia plus ultrasound guided paravertebral block with 20 ml bupivacaine 0.2%	Procedure: ultrasound guided paravertebral block patients will receive combined general anesthesia and ultrasound guided paravertebral block with 20 ml of bupivacaine 0.2 %
Active Comparator: general anesthesia general anesthesia plus morphine 0.1mg/kg for analgesia	Drug: conventional analgesia patients will receive combined general anesthesia and conventional analgesia

Arm

Intervention/Treatment

Active Comparator: general anesthesia+ US guided erector spinae plane block

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

Procedure: 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 %.

Active Comparator: general anesthesia+ US guided paravertebral block

General anesthesia plus ultrasound guided paravertebral block with 20 ml bupivacaine 0.2%

Procedure: ultrasound guided paravertebral block

patients will receive combined general anesthesia and ultrasound guided paravertebral block with 20 ml of bupivacaine 0.2 %

Active Comparator: general anesthesia

general anesthesia plus morphine 0.1mg/kg for analgesia

Drug: conventional analgesia

patients will receive combined general anesthesia and conventional analgesia

Outcome Measures

Primary Outcome Measures

First time to analgesic requirement [1st 24 hour]
morphine (0.1 mg/kg) will be given as the first rescue.After half an hour of the second rescue analgesia,in all patients Numerical rating scale (NRS) will be used for pain assessment (0=no pain -10= the worst pain), if the patient still had NRS >4, additional morphine will be given to a maximum of 10 mg in 6 hours or a total of 40 mg in 24 hours.

Secondary Outcome Measures

total analgesic consumption [1st 24 hour]
The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Numerical rating scale (NRS) [1st 24 hour]
All patients will be monitored in the postoperative period for pain by the NRS score at rest and movement at immediate postoperative (0 min), 30 min, 1, 2, 6,12, and 24 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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) I or II.

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
history of allergy to opioids, or local anaesthetics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05448469

Other Study ID Numbers:

R 97/2022

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

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

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

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Jul 11, 2022