Infiltration Analgesia After Caesarean Section

Phase 4

Completed

• Conditions: Pain, Postoperative; Caesarean Section
• Interventions: Drug: NaCl 0,9%; Drug: Ropivacaine 0,75%

• Registration Number: NCT01094106
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Study Start: 2010-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2020-07-05
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Results First Posted: 2020-08-18
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0,9%	NaCl 0,9%	Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Ropivacaine 0,75%	Ropivacaine 0,75%	Postoperative wound infusion 15 mg /h / 48h

Primary Outcome Measures

Name	Time	Method
The Demand of Rescue Analgesics (Oxycodone)	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Strength of Pain on Numerical Rating Scale (NRS)	48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)	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.
Postoperative Nausea and Vomiting (PONV)	48 hours	The numbers of patients with at least mild nausea at any time post-operatively.

Trial Locations

Locations (1)

North Karelia Central hospital; 🇫🇮 Joensuu, Finland