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

Primary Purpose

Analgesia

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided erector spinae plane block
ultrasound guided paravertebral block
conventional analgesia
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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) 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.

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

general anesthesia+ bilateral US guided erector spinae plane block

general anesthesia+ bilateral US guided paravertebral block

general anesthesia

Arm Description

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

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

general anesthesia plus conventional analgesia

Outcomes

Primary Outcome Measures

First time to analgesic requirement
all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine.

Secondary Outcome Measures

total analgesic consumption
The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Numerical rating scale (NRS)
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.

Full Information

First Posted
July 2, 2022
Last Updated
December 21, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05448469
Brief Title
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy
Official Title
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
general anesthesia+ bilateral US guided erector spinae plane block
Arm Type
Active Comparator
Arm Description
General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9
Arm Title
general anesthesia+ bilateral US guided paravertebral block
Arm Type
Active Comparator
Arm Description
General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10
Arm Title
general anesthesia
Arm Type
Active Comparator
Arm Description
general anesthesia plus conventional analgesia
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided erector spinae plane block
Intervention Description
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
Intervention Name(s)
ultrasound guided paravertebral block
Intervention Description
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
Drug
Intervention Name(s)
conventional analgesia
Intervention Description
patients will receive combined general anesthesia and conventional analgesia
Primary Outcome Measure Information:
Title
First time to analgesic requirement
Description
all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine.
Time Frame
1st 24 hour
Secondary Outcome Measure Information:
Title
total analgesic consumption
Description
The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Time Frame
1st 24 hour
Title
Numerical rating scale (NRS)
Description
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.
Time Frame
1st 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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