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Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia (Analgesia)

27 aprile 2026 aggiornato da: Bashu Dev Parajuli, Tribhuvan University Teaching Hospital, Institute Of Medicine.

Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial

Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.

Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.

Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Pooja Poudyal, MD Obstetric and Gynaecology
  • Numero di telefono: 00977+9841526853
  • Email: paudyalpooja@yahoo.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
  • ASA II/ III
  • Maternal Height > 150 cm
  • BMI< 40 Kg/m2
  • Elective Indication

Exclusion Criteria:

  • Patient unwilling to take part in the study
  • Patient with known allergy to the study medications
  • Contraindication to Spinal Anesthesia

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Group BF
Intrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml), total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added.
Droga: 0.5% bupivacaine heavy with fentanyl
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
Sperimentale: Group BF-M50
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention
Droga: 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 50mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
Sperimentale: Group BF-M100
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention
Droga: 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 100mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
Sperimentale: Group BF-M150
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention
Droga: 0.5% bupivacaine heavy with fentanyl plus morphine 150mcg
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 150mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Lasso di tempo: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain. The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable". The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To compare the first rescue analgesia demand time among the four groups
Lasso di tempo: Postoperative period after cesarean delivery till 24 hour
Rescue analgesia demand is defined as the first time after the cesarean section when the NRS score > 3, and analgesic will be needed. The time period after cesarean section when first rescue analgesic is needed will be compared among the four group. Inj.Ketorolac 30 mg iv will be supplemented first as rescue analgesic and recorded.
Postoperative period after cesarean delivery till 24 hour
To compare the total analgesic consumption in first 24 hours among the parturient of four group
Lasso di tempo: Postoperative total analgesia consumption for first 24 hour
Total analgesia consumption is defined as the total amount of paracetamol, ketorolac and tramadol received in the first 24 hours. From the time of first dose of ketorolac, regular analgesia will be prescribed as inj. ketorolac 30mg iv 8 hourly and inj. paracetamol 1gm iv 6 hourly for 24 hour. If the NRS score >3 at any point of time apart from the regular above medication, then Inj. tramadol 50 mg iv SOS will be provided and recorded. The number pf parturient with total analgesics consumption in 24 hour will be compared among the four groups.
Postoperative total analgesia consumption for first 24 hour
To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups
Lasso di tempo: Postoperative period for first 24 hour
Frequency of rescue analgesia demand is measured by number of time patient with NRS >3 who demand for iv ketorolac, paracetamol and tramadol despite providing regular analgesia (inj ketorolac 30mg iv 8 hourly and inj.paracetamol 1gm iv 6 hourly) for 24 hour.
Postoperative period for first 24 hour
To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups
Lasso di tempo: Postoperative period for first 24 hour

Number of parturient with treatment related side effects like nausea, vomiting, pruritus, respiratory depression and level of sedation are assessed and compared among the groups. Level of sedation is assessed by Pasero Opioid - Induced Sedation Scale (POSS) This score consist:

of : S Sleepy, easy to arouse

  1. Awake and alert
  2. Slightly drowsy, easily arousable
  3. Frequently drowsy, arousable, drift off to sleep during conversation
  4. Somnolent, minimal or no response to verbal or physical stimulation A POSS score of S, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation.
Postoperative period for first 24 hour

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

28 dicembre 2026

Completamento dello studio (Stimato)

28 dicembre 2026

Date di iscrizione allo studio

Primo inviato

2 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRC/IOM/D-2026-339
  • NHRC 772-2025 (Altro identificatore: NHRC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual patient personal data will be kept confidential as our local IRC won't allow us to breach this policy.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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