Comparison Between Erector Spinae Plane Block vs Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section
Erector Spinae Plane Block Versus Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section: Comparative Randomized Prospective Study
This study is a prospective randomized controlled trial designed to compare the effectiveness of the erector spinae plane (ESP) block versus the transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing cesarean section under spinal anesthesia. Sixty patients will be randomly allocated into two equal groups to receive either ESP or TAP block after surgery.
The primary outcome of the study is the assessment of postoperative pain using the Numeric Rating Scale (NRS) over the first 24 hours. Secondary outcomes include total morphine consumption, time to first request for rescue analgesia, patient satisfaction, incidence of complications, and hemodynamic stability.
All patients will receive standardized spinal anesthesia followed by the assigned block using a combination of bupivacaine and lidocaine under ultrasound guidance. Postoperatively, a multimodal analgesic regimen will be applied, including regular paracetamol and rescue analgesia with ketorolac or morphine based on pain scores.
The rationale of the study is based on the limitation of the TAP block in providing only somatic analgesia, whereas the ESP block may offer both somatic and visceral pain control due to its wider spread. Therefore, the study aims to determine whether ESP block provides superior postoperative analgesia and reduces opioid requirements compared to TAP block after cesarean delivery.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mohamed ali Elyamany, resident
- Telefonnummer: 01061646235
- E-post: aboelyamany@gmail.com
Studiesteder
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Sohag, Egypt
- Sohag faculty of medicine
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Ta kontakt med:
- mohamed elyamany, resident
- Telefonnummer: 01061646235
- E-post: aboelyamany@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Age from 18 to 40 years old.
- Pregnant women.
- Scheduled for lower-segment cesarean section.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Singleton pregnancy at ≥37 weeks' gestation.
Exclusion Criteria:
• Contraindications to regional blocks or local anesthetics.
- History of chronic analgesic use or opioid dependency.
- Coagulopathy or anticoagulant therapy.
- Local infection at the injection site.
- Allergy to study medications.
- Patient refusal.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: ESPB group
patients included in this group will receive the erector spinae plane block.
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For the ESP block, patients will be placed in the right lateral decubitus position, and the T9 transverse process will be identified using a high-frequency linear ultrasound probe positioned 2-3 cm lateral to the midline in a parasagittal orientation.
After skin sterilization, a 21-gauge echogenic block needle will be advanced in-plane cranio-caudally until contact with the transverse process is achieved.
Hydrodissection with sterile saline will be performed to confirm correct fascial plane placement beneath the erector spinae muscle.
A total of 20 mL local anesthetic mixture will be administered on each side, consisting of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, ensuring that the maximum safe dose is not exceeded.
Correct spread will be confirmed under ultrasound by observing separation of the fascial layers.
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Aktiv komparator: TAP group
patients included in this group will receive the transversus abdominis plane block.
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For the TAP block, patients will be placed supine, and the posterior approach will be used with the probe placed midway between the subcostal margin and the iliac crest in the anterior axillary line.
The fascial plane between the internal oblique and transversus abdominis muscles will be visualized until it tapers toward the quadratus lumborum.
A 21-gauge echogenic needle will be introduced in-plane from anterior to posterior, and hydrodissection with sterile saline will be performed to confirm the correct plane.
A total of 20 mL local anesthetic mixture will be administered per side, composed of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, with care taken to remain within safe dosage limits.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Postoperative pain scores assessment using the Numeric Rating Scale (NRS).
Tidsramme: Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
Pain scores will be evaluated both at rest and during movement.Patients will be informed about Numerical Rating Scale (NRS) and asked to circle the number between 0 and 10, Zero means no pain and ten means the worst pain].
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Total morphine consumption
Tidsramme: the first 24 hours postoperatively.
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• Total morphine consumption in the first 24 hours postoperatively.
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the first 24 hours postoperatively.
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Time to first request for rescue analgesia.
Tidsramme: during the first 24 postoperative hours.
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during the first 24 postoperative hours.
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Patient satisfaction scores
Tidsramme: at 24 hours.
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Degree of patient satisfaction will be assessed on a 5-point likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied) (10).
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at 24 hours.
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Incidence of block-related complications
Tidsramme: first 24 hours postoperatively.
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Adverse events: local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication.
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first 24 hours postoperatively.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- soh-Med-26-3-10MS
Plan for individuelle deltakerdata (IPD)
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