Infiltration Analgesia After Caesarean Section

Pain, Postoperative Clinical Trial

Official title:

Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094106
• Other study ID #: NCCHAne001
• Status: Completed
• Phase: Phase 4
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: August 2020
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Caesarean Section
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0,75%
Postoperative wound infusion 2 ml/ h/ 48h
• NaCl 0,9%
Postoperative wound infusion 2 ml/h/48h

Locations

Country	Name	City	State
Finland	North Karelia Central hospital	Joensuu

Sponsors (1)

Lead Sponsor	Collaborator
North Karelia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Demand of Rescue Analgesics (Oxycodone)	The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.	48 hours
Secondary	Strength of Pain on Numerical Rating Scale (NRS)	Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.	48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)
Secondary	Postoperative Nausea and Vomiting (PONV)	The numbers of patients with at least mild nausea at any time post-operatively.	48 hours