Infiltration Analgesia After Caesarean Section

• Sponsor: North Karelia Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01094106
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Postoperative Nausea and Vomiting (PONV) [48 hours]

   The numbers of patients with at least mild nausea at any time post-operatively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
• ClinicalTrials.gov Identifier: NCT01094106
• Other Study ID Numbers: NCCHAne001
• First Posted: Mar 26, 2010
• Last Update Posted: Aug 18, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Sanna Kouhia, MD, North Karelia Central Hospital: postoperative pain; infiltration analgesia; ropivacaine; Caesarean Section
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

Participant Flow

Pre-assignment Detail	Three patients were excluded after recruitment and randomisation, for the following reasons: For one patient, an emergency operation was needed before the scheduled operation time; for one patient, the hospital pharmacy was unable to provide the study drug in time, and for one patient, no study drug was initiated because of communication errors.

Arm/Group Title	Ropivacaine 0,75%	NaCl 0,9%
Arm/Group Description	Postoperative wound infusion 15 mg /h / 48h Ropivacaine 0,75%: Postoperative wound infusion 2 ml/ h/ 48h	Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h NaCl 0,9%: Postoperative wound infusion 2 ml/h/48h
Period Title: Overall Study
STARTED	33	34
COMPLETED	33	34
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ropivacaine 0,75%	NaCl 0,9%	Total
Arm/Group Description	Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h	Total of all reporting groups
Overall Participants	33	34	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.1 (5.7)	30.9 (5.7)	30.5 (5.7)
Sex: Female, Male (Count of Participants)
Female	33 100%	34 100%	67 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Finland	33 100%	34 100%	67 100%
Weight, kg (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	75.8 (12.6)	80.6 (17.2)	78.2 (15.2)
Height, cm (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	162.4 (5.7)	162.9 (6.4)	162.6 (6.0)
Dose of spinal bupivacaine, mg (mg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg]	11.9 (0.8)	11.7 (0.8)	11.8 (0.8)
Length of operation, min (min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min]	50.6 (18.3)	46.6 (13.8)	47.0 (16.2)

Outcome Measures

1. Primary Outcome

Title	The Demand of Rescue Analgesics (Oxycodone)
Description	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.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ropivacaine 0,75%	NaCl 0,9%
Arm/Group Description	Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Measure Participants	33	34
Mean (Standard Deviation) [mg]	47.5 (20.9)	57.8 (29.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Strength of Pain on Numerical Rating Scale (NRS)
Description	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.
Time Frame	48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ropivacaine 0,75%	NaCl 0,9%
Arm/Group Description	Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Measure Participants	33	34
Highest recorded pain scores at rest, 0-6 h	5	6
Highest recorded pain scores at rest, 6-12 h	3	3.75
Highest recorded pain scores at rest, 12-24 h	3	3
Highest recorded pain scores at rest, 24-36 h	2.25	3
Highest recorded pain scores at rest, 36-48 h	1	2
Highest recorded pain scores when moving, 0-6 h	6.5	7
Highest recorded pain scores when moving, 6-12 h	5	6
Highest recorded pain scores when moving, 12-24 h	5	5.75
Highest recorded pain scores when moving, 24-36 h	4.25	5
Highest recorded pain scores when moving, 36-48 h	3	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores at rest, 0-6 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores at rest, 6-12 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores at rest, 12-24 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores at rest, 24-36 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores at rest, 36-48 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores when moving, 0-6 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores when moving, 6-12 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores when moving, 12-24 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores when moving, 24-36 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments	Highest recorded pain scores when moving, 36-48 h
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	No adjustments for multiple comparisons
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Postoperative Nausea and Vomiting (PONV)
Description	The numbers of patients with at least mild nausea at any time post-operatively.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ropivacaine 0,75%	NaCl 0,9%
Arm/Group Description	Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Measure Participants	33	34
Number [participants]	7 21.2%	11 32.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0,75%, NaCl 0,9%
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Ropivacaine 0,75%		NaCl 0,9%
Arm/Group Description	Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h		Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
All Cause Mortality
	Ropivacaine 0,75%		NaCl 0,9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ropivacaine 0,75%		NaCl 0,9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Ropivacaine 0,75%		NaCl 0,9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/33 (3%)		2/34 (5.9%)
Skin and subcutaneous tissue disorders
Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion	1/33 (3%)		1/34 (2.9%)
Smarting of the wound	0/33 (0%)		1/34 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.