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Comparison the Effect of Adding Two Different Doses of Dexmedetomidine to Ropivacaine on Pain After Cesarean Section

Comparison of Local Subcutaneous Infiltration with Ropivacaine Alone or Two Different Doses of Dexmedetomidine plus Ropivacaine for Postoperative Pain After Cesarean Section Under Spinal Anesthesia.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221122056579N1
Enrollment
90
Registered
2022-12-04
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Postoperative Pain after Cesarean Section, The effect of ropivacaine and dexmedetomidine drugs.

Interventions

Intervention 1: The first intervention group, In this group, at the end of the operation, before closing the wound, dexmedetomidine with a dose of 1 microgram/kg is injected into the patient in the fo

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for cesarean surgery (for the first time) Performing cesarean surgery under spinal anesthesia ASA I&II (American society of anesthesiologists)

Exclusion criteria

Exclusion criteria: Patients with a History of Drug Allergy (Dexmedetomidine And Ropivacaine) Patients with a History of Tobacco and Opioid Addiction Patients with Psychological Problems Obese Patients Weighing More Than 100 kg Patients with Inability to Express Pain Score Suffering from Intracranial Hypertension Twin Pregnancy and Above Previous Abdominal and Pelvic Surgeries Uncontrollable Underlying Disease (ASA3 and higher)

Design outcomes

Primary

MeasureTime frame
Pain after cesarean section based on Visual Analogue Scale. Timepoint: Pain at baseline (before spinal anesthesia) and then every 15 minutes during recovery and after that at 2, 4, 6, 12, 24 hours after surgery in the ward. Method of measurement: Visual Analogue Scale, It is evaluated based on a score from 0 (no pain) to 10 (severe pain).

Secondary

MeasureTime frame
The amount of additional analgesic. Timepoint: If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain. Method of measurement: The number of diclofenac sodium suppositories 100 mg.;The first time to receive analgesics. Timepoint: If the patient's VAS is more than 4 cm, diclofenac sodium suppository 100 mg is used to relieve pain. Method of measurement: Number of minutes after surgery.;• The incidence of side effects include: nausea and vomiting, chills, hallucinations, hypotension (<30% of baseline), bradycardia (<60), hypertension and tachycardia (increase of more than 30% compared to baseline), Respiratory depression (< 10 times per minute). Timepoint: After recovery until discharge. Method of measurement: has/doesn't have.;Patient satisfaction based on VAS. Timepoint: in hours 2, 4, 6, 12, 24 after entering the ward. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefeh Ghosouri

Esfahan University of Medical Sciences

arefeh1377kabirzadeh@gmail.com+98 31 4263 3519

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026