Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Post Operative Pain Clinical Trial

Official title:

Multimodal Intrathecal Analgesia for Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186454
• Other study ID #: 2008
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: January 2022
• Source: Sohag University
• Contact: Fouad Soliman
• Phone: 01113815186
• Email: fouad_soliman[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 15, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion criteria:

• ASA I-II
• Age 20-40 years.
• Pregnant women with living fetus.
• Body mass index 20- 35 kg/m2.

Exclusion criteria:

• Patient refusal.
• Age < 20 or > 40 years
• Body mass index < 20 or > 35.
• Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
• Placental abnormalities: placental abruption, placenta previa or accrete.
• Allergy to drugs used in the study.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Morphine Sulfate
analgesia
• Bupivacaine
Analgesia
• dexamethasone, morphine, midazolam
1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam

Locations

Country	Name	City	State
Egypt	Fouad Soliman	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st analgesic requirement	The first time of supplemental analgesic need postoperatively	24 hours
Secondary	Analgesic consumption	Total analgesic consumption	24 hours
Secondary	Post operative pain	Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)	24 hours
Secondary	Side effects	Pruritus (assessed the number of patients suffering from pruritus and grading the degree as follow:Mild= Itching is a minor concern, Moderate = Itching is a primary concern, but bearable,Severe= Unbearable; patient need anti-histaminic treatment.; Nausea and/or vomiting(assessed on 4 grade scales: 0= no symptoms present, 1 =mild nausea with no need for pharmacological treatment, 2= moderate nausea that required treatment (ondansetron 4 mg), 3= severe nausea that is resistant to treatment).; 3-Sedation (assessed on 4 grade scale: 1-awake and alert, 2 -slightly drowsy, easily aroused, 3 -drowsy, drifts off to sleep during conversation, 4 -somnolent, minimal, or no response to physical stimulation).; 4- Respiratory depression whether present or not(Respiratory depression was defined as a respiratory rate =10/min.)	24 hours