Clinical trial NCT03458078: Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.
Official title: Comparison of the Analgesic Efficacy of Two Adjuvants to Hyperbaric Bupivacaine During Spinal Anaesthesia for Caesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: Bupivacaine,
Anesthetics
Adjuvants
Analgesics
Peripheral system
Central Nervous
sensory system
Agents
Physiological effects of drugs
opioid
Pain
Postoperative
Signs and Symptoms
Lead sponsor: Centre de Maternité de Monastir
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The patients were randomly allocated using a computer-generated randomization list to one of three groups that contained 50 parturients each via www.randomization.com.

Group C (control group): 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.

Group Mg (magnesium sulfate group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).

Group MDZ (midazolam group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazolam (0.4 + 0.6cc physiological saline (1 ml)).

The parturients as well as the anesthetist who evaluated the protocol did not know the nature of the adjuvant injected in spinal anesthesia. The presented syringe contained one of the two adjuvants or the physiological serum in the same volume and of the same appearance. It was prepared by an anesthesist who was not included in the analysis of the study and was presented anonymously to the anesthetist in charge of the patient. A postoperative monitoring (PO) was performed during the first 24 hours in the intensive care unit by the anesthesist who did not know the nature of the injected adjuvant. All patients were kept nil per os for six hours prior to surgery.

Eligibility 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.

Primary outcomes:
measure: The first requirement for analgesic
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: The sensory blocks
timeFrame: 24 hours postoperative
measure: The motor block
timeFrame: 24 hours postoperative
measure: Hypotension
timeFrame: 24 hours post operative
measure: Bradycardia
timeFrame: 24 hours post operative
measure: Sedation Score
timeFrame: 24 hours post operative
measure: Maternal satisfaction
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Chu Tahar Sfar
city: Monastir
country: Tunisia
facility: Centre de Maternité de Monastir
Study officials:
affiliation: CHU TAHAR SFAR MAHDIA
name: Rim Cherif, Dr.
role: STUDY_DIRECTOR
References:
citation: Zakeri H, Pouralborz Y, Askari A, Parkhah M, Hosseinipour A. The adjunctive midazolam or magnesium sulfate to intrathecal bupivacaine analgesic effect in caesarean section: a randomized controlled trial. Biomedical Research. 2017; 28: 3783-3787.