Continuous Infusion for Pain Relief

Regional Anesthesia Clinical Trial

Official title:

Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02711072
• Other study ID #: tunisian hh2
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 14, 2016
• Start date: March 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Tunisian Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-II

• 18-45 years of age, inclusive

• elective caeserean section under spinal anesthesia

Exclusion Criteria:

• - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)

• existing neurological deficit

• inability to understand the informed consent and demands of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caeserian Section
• Local Anesthetic
• Regional Anesthesia

Intervention

Drug:
• control group
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h
• infiltration group
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tunisian Military Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogic Scale	quality of postoperative analgesia	until 48 hours postoperative	No
Secondary	occurrence of complications		48 hours post operative	No
Secondary	total dose of morphine consumption in mg		during 48 hours post operative	No