Health TrialsbyHealthPanel

Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

ConditionPost Operative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorUniversity of Tennessee

About this trial

The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 18 to 80

BMI 55.0 or less

Laparoscopic hysterectomy surgery planned

Disqualifiers

Women younger than 18 or older than 80 years of age

BMI over 55.0

Laparoscopic hysterectomy surgery not planned

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lower Insufflation Pressure

    Procedure/Surgery

    Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery.

  • Standard Insufflation Pressure

    Procedure/Surgery

    Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 12 mmHg Insufflation PressureExperimental treatment 1 intervention
Group B: 15 mmHg Insufflation PressureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain on postoperative day 1

All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

Time frame
24 hours following surgery

Secondary outcomes

1

Preoperative pain

All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

Time frame
Within 2 hours before surgery
2

Postoperative pain while in PACU

All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

Time frame
Approximately 2 hours after surgery completion
3

Postoperative pain at follow-up visit

All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

Time frame
Approximately 2 weeks after surgery completion
4

Opioid use after discharge

All participants will be asked about the number of prescription opioid pills they took following discharge.

Time frame
Within 2 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee

Lead sponsor

Source ClinicalTrials.gov
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