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Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy

19. juli 2026 opdateret af: Ahmed Samir Abdelmonaem, Sohag University

Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study

This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria Patients scheduled to undergo elective or emergency midline exploratory laparotomy.

American Society of Anesthesiologists (ASA) physical status I, II, or III. Intact cognitive ability to comprehend study procedures, use the Numeric Rating Scale (NRS) accurately, and provide informed consent.

Exclusion Criteria Contraindications to regional or neuraxial anesthesia (e.g., patient refusal, localized infection at needle insertion sites, known coagulopathy (INR >1.5 or platelet count <80,000/\mu L), or un-pausable therapeutic anticoagulation).

Known allergy or severe hypersensitivity to local anesthetics or morphine. Chronic pain conditions requiring daily opioid consumption for >3 months preoperatively.

Documented history of substance use disorder. Severe chronic respiratory disease (e.g., COPD requiring home oxygen therapy, or severe obstructive sleep apnea not managed with CPAP).

Neurological or psychiatric conditions that compromise sensory perception or communication.

Surgical incisions planned to extend significantly past the midline. Severe spinal deformities or a history of spinal surgery at the targeted block/injection interspaces.

Concurrent enrollment in any other interventional clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intrathecal morphine alone
Drug: Intrathecal Morphine (ITM) Under sterile conditions preoperatively, a 25-gauge spinal needle is introduced at the L3-L4 or L2-L3 interspace. A 1.0 mL solution containing 100 µg of preservative-free morphine (diluted with 0.9% normal saline) is injected intrathecally upon free CSF flow. No ESPB is performed.
Medicin: Intrathecal Morphine
Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
Andre navne:
  • Spinal morfin
  • ITM
Aktiv komparator: Bilateral Erector Spinae Plane Block
Procedure: Bilateral Erector Spinae Plane Block Preoperatively, using a high-frequency linear ultrasound probe at the T8 vertebral level, an echogenic needle is inserted in-plane deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration, 20 mL of 0.25% isobaric bupivacaine is injected. The procedure is repeated on the opposite side. No ITM is performed.
Procedure: Erector Spinae Plane Block
Bilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.
Andre navne:
  • ESBP
  • Ultrasound-guided ESPB
Eksperimentel: Intrathecal morphine + Bilateral Erector Spinae Plane Block
Combination Regimen Patients receive both interventions preoperatively. The bilateral T8 ESPB (20 mL 0.25% bupivacaine per side) is performed first in the lateral decubitus position, followed immediately by the lumbar L2-L3 or L3-L4 ITM injection (100 mcg preservative-free morphine).
Medicin: Intrathecal Morphine
Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
Andre navne:
  • Spinal morfin
  • ITM
Procedure: Erector Spinae Plane Block
Bilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.
Andre navne:
  • ESBP
  • Ultrasound-guided ESPB

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Rescue Analgesia
Tidsramme: Up to 48 hours postoperatively.
Duration of time (in minutes/hours) elapsed from PACU admission to the patient's first request for an IV morphine rescue bolus.
Up to 48 hours postoperatively.
Postoperative Pain Intensity
Tidsramme: At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.
Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.
Cumulative Opioid Consumption
Tidsramme: Up to 48 hours postoperatively.
Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).
Up to 48 hours postoperatively.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Ambulation
Tidsramme: Up to hospital discharge (typically up to 7 days).
Time taken (in hours) from the end of surgery until the patient is able to walk more than 5 meters with assistance.
Up to hospital discharge (typically up to 7 days).
Time to Readiness for PACU Discharge
Tidsramme: Within the first 24 hours postoperatively.
Time in minutes from PACU admission until the patient achieves a modified Aldrete score \ge9.
Within the first 24 hours postoperatively.
Incidence of Adverse Events
Tidsramme: Up to 48 hours postoperatively.
Presence or absence (percentages) of respiratory depression (RR <8/min or SpO_2 <90% on room air), PONV requiring treatment, or pruritus requiring treatment.
Up to 48 hours postoperatively.
Patient Satisfaction with Pain Management
Tidsramme: Assessed at 48 hours postoperatively.
Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied).
Assessed at 48 hours postoperatively.
Quality of Recovery
Tidsramme: Postoperative Day 1 (approximately 24 hours).
Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire.
Postoperative Day 1 (approximately 24 hours).
Healthcare Utilization
Tidsramme: From day of surgery to hospital discharge (up to 30 days).
Total length of hospital stay measured in days.
From day of surgery to hospital discharge (up to 30 days).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sohag University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

19. juli 2026

Først indsendt, der opfyldte QC-kriterier

19. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Soh-Med-26-6-13MS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared outside the research team to protect patient privacy, maintain strict data confidentiality regarding clinical interventions, and comply with institutional data management policies.

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Kliniske forsøg med Postoperativ smerte

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