Overview

Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.

Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
0
Participant gender:
Female
Summary
: Pain modulation is very important after operation, particularly for women who undergo caesarean section. A pain-free postoperative period is essential following a caesarean section so new mothers may care for and bond with their neonates. The consequences of the improper pain management which raise the healthcare costs and prolong the recovery process. Intrathecal adjuvants are often administered during this procedure to provide significant analgesia, but they may also have bothersome side effects. Intrathecal midazolam and magnesium sulfate produces effective postoperative analgesia with no significant side effects. Objectives: This prospective, randomized, double-blind study was designed to compare the analgesic efficacy and safety of intrathecal midazolam vs. Magnesium sulfate vs plain bupivacaine as an adjunct to bupivacaine in pregnancy patients scheduled for elective caesarean section.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Centre de Maternité de Monastir
Treatments:
Analgesics
Bupivacaine
Magnesium Sulfate
Midazolam
Criteria
Inclusion Criteria:

- a mono fetal pregnancy, term> 35 week, planned caesarean section under spinal
anesthesia, six-hour fasting, and the American Society of Anesthesiologists (ASA)
physical status I or II.

Exclusion Criteria:

- contraindication for intrathecal injection, known allergies to midazolam, other
benzodiazepines, magnesium sulfate, caesarean section in extreme urgency, preeclamptic
parturient, foetal death in utero, premature delivery (<32SA), anomaly of the
placentation, any significant cardiovascular or hepatorenal diseases, a history of
seizures or convulsive neurological disease, an altered coagulation profile. Exclusion
criteria: failure of spinal anesthesia, conversion into general anesthesia, anesthetic
or surgical perioperative incident requiring resuscitation, traumatic puncture,
occurrence of serious complication of spinal anesthesia, loss of blindness or
randomization of patients.