Trial Outcomes & Findings for Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination (NCT NCT02439281)
NCT ID: NCT02439281
Last Updated: 2019-07-23
Results Overview
The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Indicated by return of normal sensation (expected average of 12 hours after block placement).
Results posted on
2019-07-23
Participant Flow
Participant milestones
| Measure |
Ropivacaine Group
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine/ Clonidine Group
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ropivacaine/ Clonidine Group
n=26 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Total
n=50 Participants
Total of all reporting groups
|
Ropivacaine Group
n=24 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=26 Participants
|
50 Participants
n=50 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
13 years
n=26 Participants
|
13 years
n=50 Participants
|
13. years
n=24 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=26 Participants
|
25 Participants
n=50 Participants
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=26 Participants
|
25 Participants
n=50 Participants
|
11 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
preoperative anxiety
|
39 units on a scale
n=24 Participants • data was available only for the patients listed, 21, respectively 24 in each group
|
35 units on a scale
n=45 Participants • data was available only for the patients listed, 21, respectively 24 in each group
|
33 units on a scale
n=21 Participants • data was available only for the patients listed, 21, respectively 24 in each group
|
PRIMARY outcome
Timeframe: Indicated by return of normal sensation (expected average of 12 hours after block placement).Population: only patients that were able to report the time when the numbness went away were analysed and compared
The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=20 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=17 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Duration of Sensory Block (Paresthesia)
|
823.5 minutes
Interval 509.5 to 1080.0
|
540 minutes
Interval 360.0 to 1015.0
|
SECONDARY outcome
Timeframe: Prior to hospital discharge (up to 24 hours after surgery)Population: only patients with satisfaction scores documented and other inclusion criteria met were analysed and compared; A numeric satisfaction scale 1-10 ( 1 not satisfied, 10 being very satisfied) was used
The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in better satisfaction with pain control.
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=20 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=16 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Satisfaction With Pain Control From Patient
|
9 units on a scale
Interval 9.0 to 10.0
|
9 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: until study completionPopulation: The patients that received a nerve block were analysed.
The investigators expect no difference in incidence of complications (e.g. oversedation, hypotension, bradycardia episodes, etc.).
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=25 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=24 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Complications Rate
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 hours after block placementPopulation: Only patients that a completed anxiety scale were analyzed . State-Trait Anxiety Inventory for Children consists of 20 statements; how they feel at that particular moment ( "I feel…"), by checking one of the three alternatives that describe the child best "very calm," "calm," or "not calm"). The total score ranges from 20-60 ( worse outcome).
The investigators hypothesize that patient postoperative anxiety scores are lower in the Ropivacaine/Clonidine group and postoperative anxiety scores decrease more in Ropivacaine /Clonidine Group, than in Ropivacaine Group.
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=18 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=23 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Change in Anxiety Scores
|
30 units on a scale
Interval 27.0 to 30.0
|
29 units on a scale
Interval 26.0 to 32.0
|
SECONDARY outcome
Timeframe: indicated by the first request for pain medication at umbilicus sitePopulation: only patients with documented duration of numbness and documented first pain scores at umbilicus were included in analysis of this secondary outcome
The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia and decreased pain scores compared to ropivacaine alone.
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=16 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=15 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Duration of Analgesia at Umbilicus Instrument Site-How Many Minutes Passed From the Time When the Blocks Where Performed Until Patient Reported Pain at Umbilicus
|
230 minutes
Interval 137.5 to 388.0
|
240 minutes
Interval 144.0 to 359.0
|
SECONDARY outcome
Timeframe: Logistic regression of the 4 th pain score assessmentPopulation: Only patients with available average pain scores at the 4 th pain assessment were compared.
Numeric Rating Pain Scores ( 0-10), will be obtained every 2 hours after PACU discharge up to 18 hours or until hospital discharge, whichever occurs first. The pain score of 0, means no pain, is a good outcome , and a pain score of 10 is excruciating pain, a very bad outcome. The average of these scores will be evaluated.The pain scores will not longer be documented after the numbness went away.
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=19 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=18 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Average Pain Severity at the Umbilicus Laparoscopic Site
|
2 units on a scale
Interval 0.0 to 2.0
|
1.5 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 18 hours after surgeryPopulation: Only patients with successful blocks were included. Two patients were deemed to have incomplete/ failed blocks and 2 patients did not have any blocks.
Total intravenous morphine equivalents mg/kg
Outcome measures
| Measure |
Ropivacaine/ Clonidine Group
n=25 Participants
Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
Ropivacaine Group
n=21 Participants
Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.
Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
|
|---|---|---|
|
Medication Consumption
|
0.20 mg/kg
Interval 0.17 to 0.24
|
0.22 mg/kg
Interval 0.15 to 0.36
|
Adverse Events
Ropivacaine/ Clonidine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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