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Trial Outcomes & Findings for Postoperative Pain Control Following Hysteroscopy (NCT NCT06423456)

NCT ID: NCT06423456

Last Updated: 2025-07-23

Results Overview

After the hysteroscopy procedure is completed, in the postoperative anesthesia care room, postoperative, 30. and 60. in minutes, 4. per hour and 24. pain measurement will be performed for patients per hour using a visual analog scale (VAS) for postoperative pain. In this scale, patients' pain between 0-10 (0=no pain, 10=very severe pain) will be questioned. Dec. The doctor who performed the measurement will not know which drug infusion was made. NSAIDs will be administered to patients with a VAS score \> 4. Opioid analgesics will be administered to patients whose pain does not go away. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

24 hours

Results posted on

2025-07-23

Participant Flow

Participant milestones

Participant milestones
Measure
Research Group
During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure. Lidocaine IV: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Control Group
In the control group, 0.9% saline solution will be used instead of lidocaine. Saline: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Overall Study
STARTED
75
75
Overall Study
COMPLETED
75
75
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperative Pain Control Following Hysteroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Research Group
n=75 Participants
During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure. Lidocaine IV: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Control Group
n=75 Participants
In the control group, 0.9% saline solution will be used instead of lidocaine. Saline: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Total
n=150 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
75 Participants
n=5 Participants
75 Participants
n=7 Participants
150 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
39.96 years
STANDARD_DEVIATION 7.87 • n=5 Participants
41.95 years
STANDARD_DEVIATION 8.83 • n=7 Participants
40.6 years
STANDARD_DEVIATION 7.91 • n=5 Participants
Sex: Female, Male
Female
75 Participants
n=5 Participants
75 Participants
n=7 Participants
150 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
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
75 Participants
n=5 Participants
75 Participants
n=7 Participants
150 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
Region of Enrollment
Turkey
75 participants
n=5 Participants
75 participants
n=7 Participants
150 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

After the hysteroscopy procedure is completed, in the postoperative anesthesia care room, postoperative, 30. and 60. in minutes, 4. per hour and 24. pain measurement will be performed for patients per hour using a visual analog scale (VAS) for postoperative pain. In this scale, patients' pain between 0-10 (0=no pain, 10=very severe pain) will be questioned. Dec. The doctor who performed the measurement will not know which drug infusion was made. NSAIDs will be administered to patients with a VAS score \> 4. Opioid analgesics will be administered to patients whose pain does not go away. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.

Outcome measures

Outcome measures
Measure
Research Group
n=75 Participants
During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure. Lidocaine IV: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Control Group
n=75 Participants
In the control group, 0.9% saline solution will be used instead of lidocaine. Saline: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.
Visual Analog Scale (VAS)
postoperatice 60th minute
1.23 score on a scale
Standard Deviation 1.07
2.40 score on a scale
Standard Deviation 1.58
Visual Analog Scale (VAS)
postoperative 30th minute
2.49 score on a scale
Standard Deviation 1.61
4.44 score on a scale
Standard Deviation 1.88
Visual Analog Scale (VAS)
postoperative 4.hour
0.61 score on a scale
Standard Deviation 0.28
1.09 score on a scale
Standard Deviation 1.08
Visual Analog Scale (VAS)
postoperative 24.hour
0.20 score on a scale
Standard Deviation 0.04
0.63 score on a scale
Standard Deviation 0.36

Adverse Events

Research Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control 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

Dr. Betül Ahat

afyonkarahisar health sciences university hospital

Phone: 05467240341

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place