Clinical Trials Logo
  1. Home
  2. Analgesia, Obstetrical
  3. NCT05099055

Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study

Analgesia Clinical Trial

Official title:
Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote

Clinical Trial Summary

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

Clinical Trial Description

52 patients will be recruted for this study, and will be randomized in two equal groups. All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics. In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine. In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment. The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics. The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire. This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05099055
Study type Interventional
Source St. Justine's Hospital
Contact
Status Completed
Phase Phase 3
Start date March 15, 2022
Completion date May 5, 2023
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A