Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia (Analgesia)
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Bashu Dev Parajuli, MD Anaesthesiology
- Telefonní číslo: 00977+ 9851179038
- E-mail: bashuparajuli2012@gmail.com
Studijní záloha kontaktů
- Jméno: Pooja Poudyal, MD Obstetric and Gynaecology
- Telefonní číslo: 00977+9841526853
- E-mail: paudyalpooja@yahoo.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
|
|
Experimentální: 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
|
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.
|
|
Experimentální: 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
|
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.
|
|
Experimentální: 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
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
Časové okno: 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".
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To compare the first rescue analgesia demand time among the four groups
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Postoperative period for first 24 hour
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
- Choudhury M. Neuraxial anaesthesia in parturient with cardiac disease. Indian J Anaesth. 2018 Sep;62(9):682-690. doi: 10.4103/ija.IJA_474_18.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Nemoci nervového systému
- Pooperační komplikace
- Patologické procesy
- Neurobehaviorální projevy
- Poruchy vnímání
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest, pooperační
- Agnosia
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, fúzované kroužek
- Alkaloidy
- Polycyklické aromatické uhlovodíky
- Polycyklické sloučeniny
- Piperidiny
- Heterocyklické sloučeniny, 4 nebo více prstenů
- Morfináni
- Alkaloidy opiátů
- Heterocyklické sloučeniny, přemostěný prsten
- Fenanthrenes
- Morfinové deriváty
- Morfium
- Fentanyl
Další identifikační čísla studie
- IRC/IOM/D-2026-339
- NHRC 772-2025 (Jiný identifikátor: NHRC)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Bolest po císařském řezu
-
East Carolina UniversityStaženo