Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.

NCT03458078 | Completed Phase 2

• 1 other identifier: CMMonastir
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• The first requirement for analgesic

  Postoperatively, the patients were observed for the duration of analgesia using the Visual Analog Scale for Pain (VAS Pain), from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at H2, H4, H6, H10, H12, H24 at rest and coughing or mobilization until supplementary analgesia was required. The duration of effective analgesia was defined as the time interval between administration of the IT drug to the time of first analgesic request or a VAS ≥ 4. Rescue analgesics were given in the form of a paracetamol injection (1g IV) as well as nefopam (20 mg IV) injection once the VAS was recorded as 4 or more.

  24 hours postoperative

Secondary Outcomes (6)

• The sensory blocks

  24 hours postoperative

• The motor block

  24 hours postoperative

• Hypotension

  24 hours post operative

• Bradycardia

  24 hours post operative

• Sedation Score

  24 hours post operative

Study Arms (3)

Group C

PLACEBO COMPARATOR

Control group

Drug: Saline Solution

Group Mg

ACTIVE COMPARATOR

Magnesium sulfate group

Drug: Magnesium Sulfate

Group MDZ

ACTIVE COMPARATOR

Midazolam group

Drug: Midazolam 5 MG/ML Injection

Interventions

Saline Solution DRUG

Spinal injection of 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.

Also known as: Saline

Group C

Magnesium Sulfate DRUG

Spinal injection of 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).

Also known as: Magnesium

Group Mg

Midazolam 5 MG/ML Injection DRUG

Spinal injection of 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)).

Also known as: Midazolam

Group MDZ

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Centre de Maternité de Monastir: lead

Study Sites (2)

Chu Tahar Sfar

Mahdia, 5100, Tunisia

Location

Centre de Maternité de Monastir

Monastir, 5000, Tunisia

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain; Signs and Symptoms

Interventions

Saline Solution; Sodium Chloride; Magnesium Sulfate; Magnesium; Midazolam; Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Rim Cherif, Dr.

  CHU TAHAR SFAR MAHDIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, clinical professor of Anesthesiology and intensive care medecine

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 8, 2018
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)