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

27 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Fase 4

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

  • Naam: Pooja Poudyal, MD Obstetric and Gynaecology
  • Telefoonnummer: 00977+9841526853
  • E-mail: paudyalpooja@yahoo.com

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:

  • 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

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: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: 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.
Experimenteel: 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
Geneesmiddel: 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.
Experimenteel: 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
Geneesmiddel: 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.
Experimenteel: 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
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Tijdsspanne: 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".

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To compare the first rescue analgesia demand time among the four groups
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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)

1 april 2026

Primaire voltooiing (Geschat)

28 december 2026

Studie voltooiing (Geschat)

28 december 2026

Studieregistratiedata

Eerst ingediend

2 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRC/IOM/D-2026-339
  • NHRC 772-2025 (Andere identificatie: NHRC)

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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