Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery

• ClinicalTrials.gov Identifier: NCT02905149
• Recruitment Status: Completed
• First Posted: September 19, 2016
• Results First Posted: March 2, 2020
• Last Update Posted: March 2, 2020
• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Information provided by (Responsible Party): Instituto de Investigacion Sanitaria La Fe

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Surgery; Breast Reconstruction
• Interventions: Procedure: Serrato; Procedure: Control
• Enrollment: 60

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Serrato	Control
Arm/Group Description	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
Period Title: Overall Study
Started	30	30
Completed	28	30
Not Completed	2	0
Reason Not Completed
Lost to Follow-up	2	0

Baseline Characteristics

Arm/Group Title		Serrato	Control	Total
Arm/Group Description		Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia	Total of all reporting groups
Overall Number of Baseline Participants		30	30	60
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants	30 participants	60 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	17 56.7%	18 60.0%	35 58.3%
	>=65 years	13 43.3%	12 40.0%	25 41.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants	30 participants	60 participants
	Female	30 100.0%	30 100.0%	60 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Spain	Number Analyzed	30 participants	30 participants	60 participants
		30	30	60

Outcome Measures

1. Primary Outcome

Title	Total Opioid Usage
Description	Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

2 participants were lost to follow up because of malfunctioning of the electronic device administering the potoperative opioid

Arm/Group Title	Serrato	Control
Arm/Group Description:	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
Overall Number of Participants Analyzed	28	30
Median (95% Confidence Interval); Unit of Measure: milligrams
	18.5; (17 to 24)	30; (26 to 35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Serrato, Control
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.05
	Comments	Not adjusted for multiple comparison
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	9
	Confidence Interval	(2-Sided) 95%; 4 to 14.5
	Estimation Comments	Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.

2. Secondary Outcome

Title	Pain at Rest and Coughing
Description	Pain at rest and coughing at 24h postoperative (Visual analogue scale 0-10 with 0 meaning no pain and 10 meaning the worst imaginable pain). High score mean worse outcomes
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serrato	Control
Arm/Group Description:	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
Overall Number of Participants Analyzed	28	30
Median (Inter-Quartile Range); Unit of Measure: units on a scale
Worst pain in 24h	4; (3 to 6)	6; (4 to 8)
Least pain in 24h	0; (0 to 0)	0; (0 to 2)
Pain interf. with activities in bed	1; (0 to 3)	1; (0 to 6)
Pain interf. with breathing or coughing	0; (0 to 0)	0; (0 to 0)

3. Secondary Outcome

Title	Time to First Opioid Administration on the Ward
Description	Time to first opioid administration on the ward
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serrato	Control
Arm/Group Description:	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
Overall Number of Participants Analyzed	28	30
Mean (95% Confidence Interval); Unit of Measure: hours
	7.95; (4.61 to 11.28)	2.9; (0.8 to 5)

4. Secondary Outcome

Title	Presence of Opioid Related Complications
Description	presence of nausea/vomit or apnea or urinary retention or ileus is assessed. It is a dicothomic composite (yes or no).
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serrato	Control
Arm/Group Description:	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
Overall Number of Participants Analyzed	28	30
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

Adverse Events

Time Frame	24 hours after surgery
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Serrato	Control
Arm/Group Description	Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Standard anesthesia Control: Standard anesthesia
All-Cause Mortality
	Serrato	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/30 (0.00%)	0/30 (0.00%)
Serious Adverse Events
	Serrato	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/30 (0.00%)	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Serrato	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/30 (0.00%)	0/30 (0.00%)

Limitations and Caveats

The blinding method cannot entirely exclude ascertainment bias.

More Information

Certain Agreements

Principal Investigators are NOT 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.

Results Point of Contact

• Name/Title: Maria Cortell
• Organization: Instituto de Investigación Sanitaria La Fe
• Phone: 961246611
• EMail: investigacion_clinica@iislafe.es

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Miñana JM, Belaouchi M. Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):52-58. doi: 10.1136/rapm-2018-000004.

• Responsible Party: Instituto de Investigacion Sanitaria La Fe
• ClinicalTrials.gov Identifier: NCT02905149
• Other Study ID Numbers: IBMS-SPB
• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Results First Submitted: October 21, 2019
• Results First Posted: March 2, 2020
• Last Update Posted: March 2, 2020