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N/A N=84 Randomized Single-blind Treatment

Decreasing Postoperative Pain Following Endometrial Ablation

Postoperative Pain

Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Postoperative Pain Score — 2.71; 1.44; 3.37; 2.81 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Bupivacaine (Drug); Normal Saline (Other)
Age
Adult · 30+ yrs
Sex
Female
Sponsor
Christiana Care Health Services
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Pain Score
2.71; 1.44; 3.37; 2.81; 2.47; 2.24
PRIMARY
Intraoperative Total Blood Loss
6.38; 7.15
PRIMARY
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
9.18; 8.74
SECONDARY
Occurrence of Intraoperative Complication
0; 0; 0; 0; 2; 1
SECONDARY
Postoperative Complication
0; 0; 1; 2; 0; 0
SECONDARY
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
3; 1; 0; 0; 8; 6
SECONDARY
Postoperative Toradol
36; 32
SECONDARY
Postoperative Anti-emetic
2; 1; 6; 1; 0; 0
SECONDARY
Time Between Recovery Initiation and Discharge
1.63; 1.59

Summary

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

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02660918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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