Infiltration Analgesia After Caesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanna Kouhia, North Carelia Central Hospital
ClinicalTrials.gov Identifier:
NCT01094106
First received: March 12, 2010
Last updated: January 1, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Caesarean Section
Drug: Ropivacaine 0,75%
Drug: NaCl 0,9%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • The demand of rescue analgesics [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    The amount of opiate analgesics requied 48 hours after operation. Rescue analgesics will be administred when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.


Secondary Outcome Measures:
  • Strength of pain on numeric rating scale (NRS) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Postoperative nausea and vomiting (PONV) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The vigor of nausea will be assessed on the numeric rating scale (NRS) 0-10. NRS values over 3 will be medicated with antiemetics.


Enrollment: 70
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacaine 0,75%
Postoperative wound infusion 15 mg /h / 48h
Drug: Ropivacaine 0,75%
Postoperative wound infusion 2 ml/ h/ 48h
Placebo Comparator: NaCl 0,9%
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Drug: NaCl 0,9%
Postoperative wound infusion 2 ml/h/48h

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094106

Locations
Finland
North Karelia Central hospital
Joensuu, Finland, 80880
Sponsors and Collaborators
North Karelia Central Hospital
Investigators
Principal Investigator: Sakari Syväoja, MD North Carelia CH, Department of Anesthesia
  More Information

No publications provided

Responsible Party: Sanna Kouhia, MD, North Carelia Central Hospital
ClinicalTrials.gov Identifier: NCT01094106     History of Changes
Other Study ID Numbers: NCCHAne001
Study First Received: March 12, 2010
Last Updated: January 1, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by North Karelia Central Hospital:
postoperative pain
infiltration analgesia
ropivacaine
Caesarean Section

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014