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

Phase 2

• Conditions: Post Operative Pain
• Interventions: Drug: Morphine Sulfate; Drug: dexamethasone, morphine, midazolam; Drug: Bupivacaine

• Registration Number: NCT05186454
• Lead Sponsor: Sohag University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-23
• Study First Submitted: 2021-12-26
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal	dexamethasone, morphine, midazolam	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally
Morphine	Morphine Sulfate	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.
Morphine	Bupivacaine	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.
Multimodal	Bupivacaine	Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Primary Outcome Measures

Name	Time	Method
1st analgesic requirement	24 hours	The first time of supplemental analgesic need postoperatively

Secondary Outcome Measures

Name	Time	Method
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	1. 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.; 2. 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.)

Trial Locations

Locations (1)

Fouad Soliman; 🇪🇬 Sohag, Egypt