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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448469
Enrollment
99
Registered
2022-07-07
Start date
2022-07-10
Completion date
2022-12-10
Last updated
2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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 .

Interventions

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

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

patients will receive combined general anesthesia and conventional analgesia

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
First time to analgesic requirement1st 24 hourall 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

MeasureTime frameDescription
total analgesic consumption1st 24 hourThe total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Numerical rating scale (NRS)1st 24 hourAll 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026