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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Serrato Control
Hide 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
Arm/Group Title Serrato Control Total
Hide 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
Hide 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
1.Primary Outcome
Title Total Opioid Usage
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serrato Control
Hide 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
Hide Description Time to first opioid administration on the ward
Time Frame First 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serrato Control
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serrato Control
Hide 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%
Time Frame 24 hours after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Serrato Control
Hide 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%) 
Hide Serious Adverse Events
Serrato Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide 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%) 
The blinding method cannot entirely exclude ascertainment bias.
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
Layout table for Results Point of Contact information
Name/Title: Maria Cortell
Organization: Instituto de Investigación Sanitaria La Fe
Phone: 961246611
EMail: investigacion_clinica@iislafe.es
Layout table for additonal information
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