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Decreasing Postoperative Pain Following Endometrial Ablation

Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02660918
Enrollment
84
Registered
2016-01-21
Start date
2016-04-30
Completion date
2017-03-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.

Detailed description

Destruction of the endometrial lining to control bothersome uterine bleeding has been implemented since 1937. Currently there are various different 'second generation' energy sources to avert such bleeding, five of which are now approved in the United States. These 5 second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy; Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial ablation is crucial, as it is intended for premenopausal women with normal uterine cavities and no desire for future fertility that are affected by heavy menstrual bleeding. Since the introduction of the initial 'second generation' device in 1997 these modalities have overtaken the industry mostly due to their ease of use and shorter operative times. Regardless, a Cochrane review finds insufficient evidence to prove superiority of these newer modalities over the traditional 'gold standard' resectoscopic technique. Endometrial ablation has been demonstrated in a variety of settings including outpatient surgical centers as well as physician's offices. Evidence suggests that microwave endometrial ablation under local anesthesia is a safe and acceptable practice. Very often, when endometrial ablation is performed as an outpatient procedure, patients are pre-medicated and then receive a paracervical injection of local anesthesia to control pain intraoperatively. When endometrial ablations are performed as an outpatient procedure through a surgical center, a variety of anesthesia techniques are employed depending on the infrastructure and human and institutional resources available. These techniques may vary from conscious sedation to general anesthesia, all of which have been proven to be acceptable methods. In this center endometrial ablations are performed as an outpatient procedure under general anesthesia with a variety of induction techniques and intraoperative pain management practices. According to physician preference, patients may receive an additional paracervical injection of local anesthetic before the procedure, immediately after, or not at all. To date, there are no studies evaluating the efficacy of local anesthetic in addition to general anesthesia for patients receiving endometrial ablation to guide physician practice. The purpose of this study is to evaluate the efficacy of local anesthetic, in addition to general anesthesia, in our large, community-based patient population, in meaningfully decreasing postoperative pain.

Interventions

DRUGBupivacaine

Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure

OTHERNormal Saline

Equal volume injection of normal saline with the same paracervical technique

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Premenopausal women * English as primary language * undergoing outpatient endometrial ablation at the Christiana Hospital Surgical Center * Indication of menorrhagia * Inication of abnormal uterine bleeding * Indication of thickened endometrium.

Exclusion criteria

* Known malignancy * weight less than 50 Kg * amide allergy * history of chronic pain * cardiac arrhythmia * dilaudid/codeine allergy * history of opioid use * inability to take opioids by mouth * uterine anomaly * previous endometrial ablation * primary language other than English.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain ScoreImmediate postoperatively through 8 hours post operation.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
Intraoperative Total Blood LossIntraoperativeAmount of operative blood lost measured in milliliters
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following DischargePostoperativeAll 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.

Secondary

MeasureTime frameDescription
Postoperative ToradolPostoperativeData was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.
Occurrence of Intraoperative ComplicationDuring SurgeryThis represents any unanticipated complication related to the endometrial ablation.
Time Between Recovery Initiation and Dischargehours between recovery initiation and dischargeTime between arrival to the recovery room after surgery and discharge to home
Postoperative Anti-emeticPostoperativeData was collected on any nausea medicine administered following the endometrial ablation.
Postoperative Complication1 Day PostoperativeAny unanticipated complication related to the endometrial ablation.
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.Predischarge from hospitalNarcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
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
41
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
41
Total82

Baseline characteristics

CharacteristicTreatmentTotalControl
Age, Continuous43.66 years
STANDARD_DEVIATION 4.54
43.47 years
STANDARD_DEVIATION 4.82
43.29 years
STANDARD_DEVIATION 5.09
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants80 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hydrothermoablation7 Participants9 Participants2 Participants
Indication for Surgery
Abnormal Uterine Bleeding
7 Participants19 Participants12 Participants
Indication for Surgery
Menorrhagia
33 Participants61 Participants28 Participants
Indication for Surgery
Thickened Endometrium
0 Participants1 Participants1 Participants
Indication for Surgery
Unknown
1 Participants1 Participants0 Participants
Insurance
Medicaid
5 Participants9 Participants4 Participants
Insurance
Medicaire
1 Participants2 Participants1 Participants
Insurance
None
0 Participants0 Participants0 Participants
Insurance
Other Private
35 Participants71 Participants36 Participants
Minerva Abltion1 Participants2 Participants1 Participants
Previous ceasrean delivery13 Participants25 Participants12 Participants
Previous dilation and curettage4 Participants7 Participants3 Participants
Previous myomectomy1 Participants2 Participants1 Participants
Previous tubal ligation13 Participants23 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
14 Participants20 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants0 Participants
Race (NIH/OMB)
White
25 Participants59 Participants34 Participants
Radiofrequency ablation33 Participants68 Participants35 Participants
Sex: Female, Male
Female
41 Participants82 Participants41 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Thermachoice balloon0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 41
other
Total, other adverse events
1 / 412 / 41
serious
Total, serious adverse events
0 / 410 / 41

Outcome results

Primary

Intraoperative Total Blood Loss

Amount of operative blood lost measured in milliliters

Time frame: Intraoperative

Population: Data was only available for 37 patients in the Control group and 33 patients in the Treatment group

ArmMeasureValue (MEDIAN)Dispersion
ControlIntraoperative Total Blood Loss6.38 ccStandard Deviation 3.7
TreatmentIntraoperative Total Blood Loss7.15 ccStandard Deviation 6.06
Primary

Postoperative Pain Score

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

Time frame: Immediate postoperatively through 8 hours post operation.

Population: not avaialble

ArmMeasureGroupValue (MEAN)Dispersion
ControlPostoperative Pain Score1 Hour Postoperative Pain Score2.71 units on a scaleStandard Deviation 2.47
ControlPostoperative Pain Score4 Hours Postoperative Pain Score3.37 units on a scaleStandard Deviation 2.48
ControlPostoperative Pain Score8 Hours Postopeartive Pain Score2.47 units on a scaleStandard Deviation 2.17
TreatmentPostoperative Pain Score1 Hour Postoperative Pain Score1.44 units on a scaleStandard Deviation 2.32
TreatmentPostoperative Pain Score4 Hours Postoperative Pain Score2.81 units on a scaleStandard Deviation 2.22
TreatmentPostoperative Pain Score8 Hours Postopeartive Pain Score2.24 units on a scaleStandard Deviation 1.83
Primary

Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge

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.

Time frame: Postoperative

Population: Data was only available for 38 patients in the Control group and 38 patients in the Treatment group

ArmMeasureValue (MEAN)Dispersion
ControlRemaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge9.18 PillsStandard Deviation 0.98
TreatmentRemaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge8.74 PillsStandard Deviation 1.52
Secondary

Occurrence of Intraoperative Complication

This represents any unanticipated complication related to the endometrial ablation.

Time frame: During Surgery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlOccurrence of Intraoperative ComplicationUterine Perfortaion0 Participants
ControlOccurrence of Intraoperative ComplicationIncomplete Ablation0 Participants
ControlOccurrence of Intraoperative ComplicationFailed Ablation2 Participants
ControlOccurrence of Intraoperative ComplicationFluid Overload0 Participants
ControlOccurrence of Intraoperative ComplicationBleeding0 Participants
TreatmentOccurrence of Intraoperative ComplicationFluid Overload0 Participants
TreatmentOccurrence of Intraoperative ComplicationBleeding0 Participants
TreatmentOccurrence of Intraoperative ComplicationUterine Perfortaion0 Participants
TreatmentOccurrence of Intraoperative ComplicationFailed Ablation1 Participants
TreatmentOccurrence of Intraoperative ComplicationIncomplete Ablation0 Participants
Secondary

Postoperative Anti-emetic

Data was collected on any nausea medicine administered following the endometrial ablation.

Time frame: Postoperative

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlPostoperative Anti-emeticBenadryl2 Participants
ControlPostoperative Anti-emeticZofran6 Participants
ControlPostoperative Anti-emeticReglan0 Participants
ControlPostoperative Anti-emeticPhenergan1 Participants
TreatmentPostoperative Anti-emeticPhenergan0 Participants
TreatmentPostoperative Anti-emeticBenadryl1 Participants
TreatmentPostoperative Anti-emeticReglan0 Participants
TreatmentPostoperative Anti-emeticZofran1 Participants
Secondary

Postoperative Complication

Any unanticipated complication related to the endometrial ablation.

Time frame: 1 Day Postoperative

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlPostoperative ComplicationBleeding0 Participants
ControlPostoperative ComplicationInfection1 Participants
ControlPostoperative ComplicationHospital Readmission0 Participants
TreatmentPostoperative ComplicationBleeding0 Participants
TreatmentPostoperative ComplicationInfection2 Participants
TreatmentPostoperative ComplicationHospital Readmission0 Participants
Secondary

Postoperative Opioid Administered Following the Procedure But Prior to Discharge.

Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.

Time frame: Predischarge from hospital

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Vicodin0 Participants
ControlPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Roxicodone15 Participants
ControlPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Dialudid8 Participants
ControlPostoperative Opioid Administered Following the Procedure But Prior to Discharge.tylenol with Codeine0 Participants
ControlPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Percocet3 Participants
TreatmentPostoperative Opioid Administered Following the Procedure But Prior to Discharge.tylenol with Codeine0 Participants
TreatmentPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Percocet1 Participants
TreatmentPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Vicodin0 Participants
TreatmentPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Dialudid6 Participants
TreatmentPostoperative Opioid Administered Following the Procedure But Prior to Discharge.Roxicodone9 Participants
Secondary

Postoperative Toradol

Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.

Time frame: Postoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlPostoperative Toradol36 Participants
TreatmentPostoperative Toradol32 Participants
Secondary

Time Between Recovery Initiation and Discharge

Time between arrival to the recovery room after surgery and discharge to home

Time frame: hours between recovery initiation and discharge

ArmMeasureValue (MEAN)Dispersion
ControlTime Between Recovery Initiation and Discharge1.63 hoursStandard Deviation 0.73
TreatmentTime Between Recovery Initiation and Discharge1.59 hoursStandard Deviation 0.55

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026