The effects of several local anesthetics in spinal anaesthesia for elective caesarean section.

The effects of sufentanil or morphine added to hyperbaric bupivacaine in spinal anaesthesia for elective caesarean section.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001430-25-ES

Enrollment

Registered

2017-06-22

Start date

2017-11-07

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

CESAREAN

Interventions

Trade Name: SUFENTANIL G.E.S. 5 MG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: SUFENTANIL CAS Number: 56030-54-7

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Pregnant with 18 years old or more - Pregnant with 36 gestational weeks or more - Elective caesarean - ASA I-II - Informed consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnant don't accept the spinal technique - Spinal technique contraindicated - ASA>II - multiple pregnant - 3 or more caesarean section previously - BMI > 40 - Language barrier - Patients with pre-eclampsy - Patients with chronic pain - Patients with psychiatric disease or drugs addiction - Patient with allergy to any drugs used

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the postoperative pain in caesarean section with hyperbaric bupivacaine 0.5% added to sufentanil (5mcg) or morphine (0.1mg). ; Secondary Objective: 1. Better analgesic quality for the mother during the surgery period. 2. Leads to a lower consumption of intravenous morphine within 24 hours after surgery. 3.leads to levels of verbal pain scales less than 3, 6, 12 and 24 hours after surgery. 4. Better satisfaction for the pain control during the 24 hours after the surgery. 5. Allows the patients a start of sedestation and earlier bipedestation. 6. Impacts in a shorter hospitalization time. 7. Causes less side effects for the mother regarding hemodynamic alterations during the surgery period, nausea, vomiting, pruritus, tremor, Urinary retention, sedation, respiratory depression, headaches, motor, sensory or autonomic deficits. 8. Evaluate in spinal anesthesia for elective cesarean what association of bupivacaine plus opioid: sufentanil or morphine found lower values in the Apgar test: at the first minute and at 5 minutes; and in the pH collected from an umbilical cord gasometry analysis. ;Primary end point(s): Timing since the spinal punction to the first morphine bolus demanded.;Timepoint(s) of evaluation of this end point: It depends on the drug administred	—

Measure

Time frame

Main Objective: Evaluation of the postoperative pain in caesarean section with hyperbaric bupivacaine 0.5% added to sufentanil (5mcg) or morphine (0.1mg). ; Secondary Objective: 1. Better analgesic quality for the mother during the surgery period. 2. Leads to a lower consumption of intravenous morphine within 24 hours after surgery. 3.leads to levels of verbal pain scales less than 3, 6, 12 and 24 hours after surgery. 4. Better satisfaction for the pain control during the 24 hours after the surgery. 5. Allows the patients a start of sedestation and earlier bipedestation. 6. Impacts in a shorter hospitalization time. 7. Causes less side effects for the mother regarding hemodynamic alterations during the surgery period, nausea, vomiting, pruritus, tremor, Urinary retention, sedation, respiratory depression, headaches, motor, sensory or autonomic deficits. 8. Evaluate in spinal anesthesia for elective cesarean what association of bupivacaine plus opioid: sufentanil or morphine found lower values in the Apgar test: at the first minute and at 5 minutes; and in the pH collected from an umbilical cord gasometry analysis. ;Primary end point(s): Timing since the spinal punction to the first morphine bolus demanded.;Timepoint(s) of evaluation of this end point: It depends on the drug administred

—

Secondary

Measure	Time frame
Secondary end point(s): Morphine consumption within 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours	—

Countries

Spain

Contacts

Public ContactMarta Reboredo Ares

Fundación Pública Andaluza Progreso y Salud

gestionensayosclinicos.fps@juntadeandalucia.es0034955040450

Outcome results

None listed

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