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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448469
• Other study ID #: R 97/2022
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: December 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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 % at T9 level bilaterally.
• 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.

Drug:
• conventional analgesia
patients will receive combined general anesthesia and conventional analgesia

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1st 24 hour
Secondary	total analgesic consumption	The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.	1st 24 hour
Secondary	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.	1st 24 hour