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

27 april 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

180

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Pooja Poudyal, MD Obstetric and Gynaecology
  • Telefonnummer: 00977+9841526853
  • E-post: paudyalpooja@yahoo.com

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Läkemedel: 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.
Experimentell: 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
Läkemedel: 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.
Experimentell: 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
Läkemedel: 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.
Experimentell: 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
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Tidsram: 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".

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To compare the first rescue analgesia demand time among the four groups
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

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Studera stora datum

Studiestart (Beräknad)

1 april 2026

Primärt slutförande (Beräknad)

28 december 2026

Avslutad studie (Beräknad)

28 december 2026

Studieregistreringsdatum

Först inskickad

2 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRC/IOM/D-2026-339
  • NHRC 772-2025 (Annan identifierare: NHRC)

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