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NCT Number: NCT07631728

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

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.

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Key information

Conditions

Pain, Post-operative Digestive System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Postoperative Complications Signs and Symptoms Urogynecologic Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Robot-assisted laparoscopic surgery for benign gynecologic indication
  • Surgery is booked for 60 minutes or longer
  • Reliable working phone number or email

Exclusion criteria

  • 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
  • Pre-existing emphysema, chronic obstructive pulmonary disease, or pneumothorax
  • Non-English speaking

Treatment and study plan

Pulmonary recruitment maneuver

Procedure

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

Other names: Pulmonary recruitment breaths, Valsalva breath

Trendelenburg position

Procedure

Trendelenburg position as opposed to neutral (supine) position

Primary outcomes

  1. Post-laparoscopy shoulder pain, 24 hour VAS

    Time frame: 24 hours post-operatively

    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.

Secondary outcomes

  1. Post-laparoscopy shoulder pain, 72 hour VAS

    Time frame: 72-hours post-operatively

    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.

  2. Pain Interference, 24 hour

    Time frame: 24 hours post-operatively

    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).

  3. Pain Interference, 72 hour

    Time frame: 72 hours post-operatively

    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).

  4. Total opioid use, 24 hr

    Time frame: 24-hours postoperatively

    total opioid use measured by MME

  5. Total opioid use, 72 hr

    Time frame: 72-hours postoperatively

    total opioid use at 72-hr postoperatively measured by total MME

  6. Time to flatus

    Time frame: up to 72-hours postoperatively

  7. Nausea and Vomiting, 24 hour

    Time frame: 24 hours post-operatively

    Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).

  8. Nausea and Vomiting, 72 hour

    Time frame: 72 hours post-operatively

    Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).

  9. Gas & Bloating, 24 hour

    Time frame: 24 hours post-operatively

    Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).

  10. Gas & Bloating, 72 hour

    Time frame: 72 hours post-operatively

    Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).

Study contacts

Contact information is provided by the study sponsor or research team.

Debbie Shim

CONTACT

[email protected]

502-561-7260

Sponsors and collaborators

Lead sponsor

Ankita Gupta

Other

Registry information

Official study title

Trendelenburg Positioning During Pulmonary Recruitment Breaths: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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