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

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05186454

Collaborator

(none)

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: Morphine Sulfate Drug: Bupivacaine Drug: dexamethasone, morphine, midazolam	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Multimodal Intrathecal Analgesia for Cesarean Section

Actual Study Start Date :

May 23, 2021

Anticipated Primary Completion Date :

Feb 10, 2022

Anticipated Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Morphine Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.	Drug: Morphine Sulfate analgesia Other Names: bupivacaine Drug: Bupivacaine Analgesia
Active Comparator: Multimodal Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally	Drug: Bupivacaine Analgesia Drug: dexamethasone, morphine, midazolam 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam

Arm

Intervention/Treatment

Active Comparator: Morphine

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.

Drug: Morphine Sulfate

analgesia

Other Names:

bupivacaine

Drug: Bupivacaine

Analgesia

Active Comparator: Multimodal

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Drug: Bupivacaine

Analgesia

Drug: dexamethasone, morphine, midazolam

1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam

Outcome Measures

Primary Outcome Measures

1st analgesic requirement [24 hours]
The first time of supplemental analgesic need postoperatively

Secondary Outcome Measures

Analgesic consumption [24 hours]
Total analgesic consumption
Post operative pain [24 hours]
Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Side effects [24 hours]
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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.