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Comparative Study Between Ultrasound Guided Paravertebral Plane Block and Erector Spinae Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy

22 mei 2026 bijgewerkt door: Ain Shams University
The intent of this study is to compare the efficacy of the erector spinae plane block (ESPB) and paravertebral plane block in reducing postoperative opioid consumption and pain in patients with total abdominal hysterectomy.

Studie Overzicht

Gedetailleerde beschrijving

The intent of this study is to compare the efficacy of the erector spinae plane block (ESPB) and paravertebral plane block in reducing postoperative opioid consumption and pain in patients with total abdominal hysterectomy. All patients will be assessed preoperatively by history taking, full physical examination, and laboratory evaluation CBC, coagulation, kidney and liver function. inform the patient about VAS score, On arrival of the patients to the operating room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. the vital signs parameters including mean arterial pressure (MAP), heart rate (HR), respiratory (RR) and SpO2 will be measured every 5 minutes recorded at base line and every 30 minutes till end of surgery. Intravenous (IV) line will be inserted and IV fluids 500ml normal saline will be started.

In the induction of general anesthesia, the patient will receive intravenous fentanyl (2 μg /kg) and propofol (2 mg/kg). atracurium (0.5 mg/kg) then tracheal intubation and the mechanical ventilator will be employed to maintain the end-tidal CO2 between 30 and 35 mmHg. Depending on the requirements of the patient, both inhaled (Sevoflurane) and intravenous (IV) atracurium will be utilized for anesthetic maintenance.

Preparation of local anesthesia 20 ml bupivacaine 0.25% for the block for each side without exceeding the toxic dose 2mg/kg [. then the block will be performed on the lateral position.

Both blocks will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath.

Group 1(Paravertebral Plane Block) (24 Patients); The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.

Group 2 (Erector Spinae Plane Block) (24 Patients); The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.

Monitor HR & MAP and if any increase more than 20% from the baseline value will receive fentanyl 50 µg IV incremental and recording total dose of fentanyl consumption

All patients receive:

Dexamethasone 8 mg IV and Ondansetron 4 mg IV

Reversal:

Neostigmine 0.05 mg/kg and Atropine 0.02 mg/kg Post-operative settings: At the end of the surgery, the patient will be kept under observation postoperatively in the recovery room for 30 min to monitor vital signs (mean arterial pressure, heart rate, respiratory rate) and the conscious level then will be discharged to the ward to be followed.

Postoperative pain: The assessment of postoperative pain will be evaluated postoperatively in the recovery room on arrival (zero time), after 30 minutes, 2,4,6,8,12,16,20, and 24 hours postoperatively in the surgical ward with visual analogue scale (1-10).

All patients will receive paracetamol 1 gm every 8 hrs. At score of3 or more, rescue analgesic 3 mg morphine iv Will be given. Total analgesic dose of morphine during first 24 hours will be recorded.

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Abbasia
      • Cairo, Abbasia, Egypte, 00202
        • Ain Shams

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • ASA I and ASA II patients.
  • Female, 30-60 years of age.
  • Scheduled for total abdominal hysterectomy.

Exclusion criteria:

  • Patient refusal of procedure or participation in the study.
  • Opioid or analgesic abuse.
  • Known allergy to study drug.
  • Any contraindication of regional anesthesia including:
  • Local infection at the site of puncture.
  • Having history of hematological disorders, including coagulation abnormality.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Paravertebral Plane Block
the group will receive paravertebral plane block, The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.
The spinous process of the 10th thoracic vertebra will be located under the ultrasound guided (USG) linear probe. Under aseptic precautions, a 22-G short-beveled needle will be inserted under ultrasonographic guidance using the in-plane approach and was directed medially between the transverse process (TP) and the pleura. The needle will traverse the superior costotransverse ligament and enter the paravertebral space, where 2 ml of normal saline will be injected. The tip of the needle will be in the paravertebral space, noting the pleura being pushed down. Then, 20 ml of 0.25% bupivacaine will be injected into the paravertebral space under USG visualization.
20 ml of 0.25% bupivacaine will be injected
Actieve vergelijker: Erector Spinea Plane Block
the group will receive Erector Spinae Plane Block; The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.
20 ml of 0.25% bupivacaine will be injected
The USG linear probe will be placed Longitudinal 3 cm lateral to T10 transverse process TP. A 22-G short-beveled needle will be inserted in the cephalad to caudal direction through the erector spinae to contact the T10 TP using the in-plane technique. After the needle made contact with TP, the plane will be confirmed by injecting 2ml of saline and depositing 20ml of 0.25% bupivacaine.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
total morphine consumption
Tijdsspanne: from the end of surgey to 24 hrs post operative
Postoperative total morphine requirements in the first 24 hours after surgery.
from the end of surgey to 24 hrs post operative

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 mei 2026

Primaire voltooiing (Geschat)

15 januari 2027

Studie voltooiing (Geschat)

20 april 2027

Studieregistratiedata

Eerst ingediend

2 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

27 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

22 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • FMASU MD354/2025

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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