Trial Outcomes & Findings for Decreasing Postoperative Pain Following Endometrial Ablation (NCT NCT02660918)
NCT ID: NCT02660918
Last Updated: 2019-08-28
Results Overview
Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale. Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome. Patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Immediate postoperatively through 8 hours post operation.
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Treatment
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
Control
Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decreasing Postoperative Pain Following Endometrial Ablation
Baseline characteristics by cohort
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.29 years
STANDARD_DEVIATION 5.09 • n=5 Participants
|
43.66 years
STANDARD_DEVIATION 4.54 • n=7 Participants
|
43.47 years
STANDARD_DEVIATION 4.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance
None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Insurance
Medicaire
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance
Other Private
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Indication for Surgery
Menorrhagia
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Indication for Surgery
Abnormal Uterine Bleeding
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Indication for Surgery
Thickened Endometrium
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Indication for Surgery
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Radiofrequency ablation
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Hydrothermoablation
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Thermachoice balloon
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Minerva Abltion
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Previous ceasrean delivery
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Previous tubal ligation
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Previous myomectomy
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Previous dilation and curettage
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate postoperatively through 8 hours post operation.Population: not avaialble
Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale. Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome. Patients
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Postoperative Pain Score
1 Hour Postoperative Pain Score
|
2.71 units on a scale
Standard Deviation 2.47
|
1.44 units on a scale
Standard Deviation 2.32
|
|
Postoperative Pain Score
4 Hours Postoperative Pain Score
|
3.37 units on a scale
Standard Deviation 2.48
|
2.81 units on a scale
Standard Deviation 2.22
|
|
Postoperative Pain Score
8 Hours Postopeartive Pain Score
|
2.47 units on a scale
Standard Deviation 2.17
|
2.24 units on a scale
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: IntraoperativePopulation: Data was only available for 37 patients in the Control group and 33 patients in the Treatment group
Amount of operative blood lost measured in milliliters
Outcome measures
| Measure |
Control
n=37 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=33 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Intraoperative Total Blood Loss
|
6.38 cc
Standard Deviation 3.7
|
7.15 cc
Standard Deviation 6.06
|
PRIMARY outcome
Timeframe: PostoperativePopulation: Data was only available for 38 patients in the Control group and 38 patients in the Treatment group
All patients were given 10 tablets of Tylenol with codeine upon discharge for pain. This Outcome measure details the remaining number of tablets after day 1.
Outcome measures
| Measure |
Control
n=38 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=38 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
|
9.18 Pills
Standard Deviation .98
|
8.74 Pills
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: During SurgeryThis represents any unanticipated complication related to the endometrial ablation.
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Occurrence of Intraoperative Complication
Fluid Overload
|
0 Participants
|
0 Participants
|
|
Occurrence of Intraoperative Complication
Bleeding
|
0 Participants
|
0 Participants
|
|
Occurrence of Intraoperative Complication
Uterine Perfortaion
|
0 Participants
|
0 Participants
|
|
Occurrence of Intraoperative Complication
Failed Ablation
|
2 Participants
|
1 Participants
|
|
Occurrence of Intraoperative Complication
Incomplete Ablation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 Day PostoperativeAny unanticipated complication related to the endometrial ablation.
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Postoperative Complication
Bleeding
|
0 Participants
|
0 Participants
|
|
Postoperative Complication
Infection
|
1 Participants
|
2 Participants
|
|
Postoperative Complication
Hospital Readmission
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predischarge from hospitalNarcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Percocet
|
3 Participants
|
1 Participants
|
|
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Vicodin
|
0 Participants
|
0 Participants
|
|
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Dialudid
|
8 Participants
|
6 Participants
|
|
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Roxicodone
|
15 Participants
|
9 Participants
|
|
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
tylenol with Codeine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: PostoperativeData was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Postoperative Toradol
|
36 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: PostoperativeData was collected on any nausea medicine administered following the endometrial ablation.
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Postoperative Anti-emetic
Benadryl
|
2 Participants
|
1 Participants
|
|
Postoperative Anti-emetic
Zofran
|
6 Participants
|
1 Participants
|
|
Postoperative Anti-emetic
Reglan
|
0 Participants
|
0 Participants
|
|
Postoperative Anti-emetic
Phenergan
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: hours between recovery initiation and dischargeTime between arrival to the recovery room after surgery and discharge to home
Outcome measures
| Measure |
Control
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 Participants
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Time Between Recovery Initiation and Discharge
|
1.63 hours
Standard Deviation .73
|
1.59 hours
Standard Deviation .55
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=41 participants at risk
Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Normal Saline: Equal volume injection of normal saline with the same paracervical technique
|
Treatment
n=41 participants at risk
Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.
Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
|
|---|---|---|
|
Infections and infestations
Potsoperative Infection
|
2.4%
1/41 • Number of events 1 • From recovery through post operative Day 1
Postoperative Infection
|
4.9%
2/41 • Number of events 2 • From recovery through post operative Day 1
Postoperative Infection
|
Additional Information
Dr. Matthew Hoffman Chair Department of OB/GYN
Christiana Care Health System
Phone: 302 733 3350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place