Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04618146

Enrollment

Registered

2020-11-05

Start date

2020-11-10

Completion date

2021-03-31

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Postoperative, Pain, Postoperative, Pruritus, Vomiting, Postoperative

Keywords

pain, morphine, cesarean section, enhanced recovery

Brief summary

This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.

Detailed description

Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Interventions

DRUGMorphine Sulfate

intrathecal low dose morphine for early return to normal activity without opioid related complications.

DRUGBupivacaine Hydrochloride

intrathecal bupivacaine 0.5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Females scheduled for cesarean section * Age: 16-45 yrs. * Gestation age \>38 weeks. * ASA I,II

Exclusion criteria

* Refusal to participate. * Significant cardiac, hepatic or renal dysfunction. * History of chronic itching problem, or hyperemesis during pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Pain postoperative	2 hours postoperatively	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

Secondary

Measure	Time frame	Description
vomiting	2 hours postoperative	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
itching	2 hours postoperative	four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
respiratory depression	4 hours postoperative	respiratory rate less than 8 breaths \\ minute

Countries

Egypt

Contacts

Primary ContactSohair A Megalla, MD

Sohair.Adeeb@minia.edu.eg+20 120 003 6447

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026