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Does Trendelenburg Positioning During Pulmonary Recruitment Breaths Affect Post-laparoscopy Shoulder Pain

ConditionsPain, Post-operativePneumoperitoneumUrogynecologic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAnkita Gupta

About this trial

The goal of this clinical trial is to evaluate whether different positioning in the operating room during removal of laparoscopic surgical gas differs in post-surgery shoulder pain. An additional goal of this study is to evaluate whether positions change other post-surgery metrics such as bloating, time to passing gas, nausea and vomiting, and time to oral intake.

Researchers will compare Trendelenburg positioning where your head is tilted down to supine (level or flat) positioning during removal of surgical gas.

Participants will be asked to complete brief surveys at 24 and 72-hours post-surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Robot-assisted laparoscopic surgery for benign gynecologic indication

Surgery is booked for 60 minutes or longer

Reliable working phone number or email

Disqualifiers

Patients with baseline opioid use

Patients with existing shoulder or neck pain

Active malignancy-related pain or surgery for malignant indication

Concomitant upper abdominal or thoracic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary recruitment maneuver

    Procedure/Surgery

    Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum

  • Trendelenburg position

    Procedure/Surgery

    Trendelenburg position as opposed to neutral (supine) position

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: PRM TrendelenburgActive comparator 2 interventions
Group B: PRM SupineActive comparator 1 intervention
Group C: Passive SupineNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Post-laparoscopy shoulder pain, 24 hour VAS

Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.

Time frame
24 hours post-operatively

Secondary outcomes

1

Post-laparoscopy shoulder pain, 72 hour VAS

Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.

Time frame
72-hours post-operatively
2

Pain Interference, 24 hour

Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire. A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).

Time frame
24 hours post-operatively
3

Pain Interference, 72 hour

Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire. A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).

Time frame
72 hours post-operatively
4

Total opioid use, 24 hr

total opioid use measured by MME

Time frame
24-hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Ankita Gupta

Lead sponsor

University of Louisville

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: