Infiltration Analgesia After Caesarean Section

NCT ID: NCT01094106

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-10-31

Brief Summary

Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.

According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.

Conditions

Pain, Postoperative; Caesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine 0,75%

Postoperative wound infusion 15 mg /h / 48h

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0,75%

Intervention Type: DRUG

Postoperative wound infusion 2 ml/ h/ 48h

NaCl 0,9%

Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h

Group Type: PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type: DRUG

Postoperative wound infusion 2 ml/h/48h

Interventions

Ropivacaine 0,75%

Postoperative wound infusion 2 ml/ h/ 48h

Intervention Type: DRUG

NaCl 0,9%

Postoperative wound infusion 2 ml/h/48h

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• volunteer
• age over 18 years
• spinal anesthesia
• ASA 1-2
• no allergy to used medications
• no medications which have effect on pain perception

Exclusion Criteria

• patient's refusal to participate
• marked systemic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Karelia Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sanna Kouhia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sakari Syväoja, MD

Role: PRINCIPAL_INVESTIGATOR

North Carelia CH, Department of Anesthesia

Locations

North Karelia Central hospital

Joensuu, , Finland

Countries

Finland

Other Identifiers

NCCHAne001

Identifier Type: -

Identifier Source: org_study_id