Trial Outcomes & Findings for Serratus Plane Block for Postoperative Pain Control (NCT NCT02865928)
NCT ID: NCT02865928
Last Updated: 2024-02-22
Results Overview
Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.
TERMINATED
PHASE4
42 participants
4 to 10 hours
2024-02-22
Participant Flow
At pre-surgical testing, approximately one week before surgery, potential subjects will be screened and recruited into the trial.
* Any physical, mental or medical condition, makes study participation inadvisable. For example, chronic pain conditions, significant medical disease, laboratory abnormalities or condition(s) that could impact a subject's ability to communicate with the study staff, complete study activities such as provide pain scores, or would otherwise contradict study participation * Patients who are pregnant or nursing. * Patients may withdraw from this study at their discretion.
Participant milestones
| Measure |
Bupivicaine HCl
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Bupivicaine HCl
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Subject is a screen failure. Miscommunication with the randomization request.
|
1
|
0
|
|
Overall Study
Patient experience and satisfaction category lost one patient in each group to follow-up call.
|
1
|
1
|
Baseline Characteristics
Serratus Plane Block for Postoperative Pain Control
Baseline characteristics by cohort
| Measure |
Bupivicaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
52.045 years
n=5 Participants
|
49.05 years
n=7 Participants
|
50.62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 to 10 hoursPostoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.
Outcome measures
| Measure |
Bupivacaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Postoperative Opioid Requirements
|
19.875 Morphine Milligram Equivalents (MME)
Standard Deviation 21.93703609496
|
17.5 Morphine Milligram Equivalents (MME)
Standard Deviation 22.124052165246
|
SECONDARY outcome
Timeframe: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.* Postoperatively, pain intensities at rest and on movement will be assessed every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, using the visual analog scale (VAS) with two anchor points; 0 being no pain and 10 being the worst pain imaginable. Pain scores were combined to find the mean and standard deviation. * The study will collect pain and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.
Outcome measures
| Measure |
Bupivacaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Postoperative Pain With Numeric Rating Scale
|
0.7818181818181 score on a scale
Standard Deviation 0.8138642058897
|
0.7536363636363 score on a scale
Standard Deviation 0.7338097362481
|
SECONDARY outcome
Timeframe: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded. * Evaluation will be performed at every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge using a standard 11-point verbal rating scale, for which "0" represents "no nausea" and 10 represents "worst nausea imaginable." Nausea and vomiting scores were combined to find the mean and standard deviation. * The study will collect nausea and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.
Outcome measures
| Measure |
Bupivacaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Postoperative Nausea and Vomiting With Verbal Rating Scale
|
0.2545454545454 score on a scale
Standard Deviation 0.4842899494217
|
0.3363636363636 score on a scale
Standard Deviation 0.8099533063187
|
SECONDARY outcome
Timeframe: 4 to 10 hoursNumber of Participants who Required Antiemetics During the Postoperative Period.
Outcome measures
| Measure |
Bupivacaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Number of Participants Who Required Antiemetics During the Postoperative Period.
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0 to 10 hoursTime to PACU discharge
Outcome measures
| Measure |
Bupivacaine HCl
n=22 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=20 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
PACU Length of Stay
|
115.8 Minutes
Standard Deviation 48.879658884157
|
144.35 Minutes
Standard Deviation 83.998292589163
|
SECONDARY outcome
Timeframe: 1 weekPopulation: One patient in each group (Bupivacaine HCI \& Normal Saline) was missing information on patient satisfaction with pain management.
This survey assessed patient experience and satisfaction. The scale ranged from "Very dissatisfied" or "1" was the minimum value. "Very satisfied" or "5" was the maximum value.
Outcome measures
| Measure |
Bupivacaine HCl
n=19 Participants
Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine
|
Normal Saline
n=19 Participants
Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline
|
|---|---|---|
|
Patient Experience and Satisfaction With a 5-point Categorial Scale
Anesthesia Satisfaction
|
4.4210526315789 score on a scale
Standard Deviation 0.6069769786668
|
4 score on a scale
Standard Deviation 1.0540925533894
|
|
Patient Experience and Satisfaction With a 5-point Categorial Scale
Surgery Satisfaction
|
4.2631578947368 score on a scale
Standard Deviation 0.9911892555667
|
4.2105263157894 score on a scale
Standard Deviation 0.6306035352846
|
Adverse Events
Bupivicaine HCl
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place