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Infiltration Analgesia After Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094106
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : January 4, 2012
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
Study Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The demand of rescue analgesics [ Time Frame: 48 hours ]
    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 :
  1. Strength of pain on numeric rating scale (NRS) [ Time Frame: 48 hours ]
  2. Postoperative nausea and vomiting (PONV) [ Time Frame: 48 hours ]
    The vigor of nausea will be assessed on the numeric rating scale (NRS) 0-10. NRS values over 3 will be medicated with antiemetics.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094106

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North Karelia Central hospital
Joensuu, Finland, 80880
Sponsors and Collaborators
North Karelia Central Hospital
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Principal Investigator: Sakari Syväoja, MD North Carelia CH, Department of Anesthesia
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Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital Identifier: NCT01094106    
Other Study ID Numbers: NCCHAne001
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: January 2012
Keywords provided by Sanna Kouhia, North Karelia Central Hospital:
postoperative pain
infiltration analgesia
Caesarean Section
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents