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

NCT07631728 | Not Yet Recruiting

• 1 other identifier: 25.0897
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain, Post-operative; Pneumoperitoneum; Urogynecologic Surgery

Keywords

Trendelenburg; pneumoperitoneum; post-laparoscopy shoulder pain; post-laparoscopy pain; gynecologic surgery

Outcome Measures

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.

  24 hours post-operatively

Secondary Outcomes (10)

• Post-laparoscopy shoulder pain, 72 hour VAS

  72-hours post-operatively

• Pain Interference, 24 hour

  24 hours post-operatively

• Pain Interference, 72 hour

  72 hours post-operatively

• Total opioid use, 24 hr

  24-hours postoperatively

• Total opioid use, 72 hr

  72-hours postoperatively

Study Arms (3)

PRM Trendelenburg

ACTIVE COMPARATOR

PRM in Trendelenburg position (to 30 degrees or greatest degree patient can tolerate) with removal of tops of laparoscopic trocars

Procedure: Pulmonary recruitment maneuver; Procedure: Trendelenburg position

PRM Supine

ACTIVE COMPARATOR

PRM in neutral position with removal of tops of laparoscopic trocars

Procedure: Pulmonary recruitment maneuver

Passive Supine

NO INTERVENTION

control group with passive evacuation of pneumoperitoneum: insufflation evacuation by removal of tops of laparoscopic trocars in neutral (supine) position

Interventions

Pulmonary recruitment maneuver PROCEDURE

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

Also known as: Pulmonary recruitment breaths, Valsalva breath

PRM Supine; PRM Trendelenburg

Trendelenburg position PROCEDURE

Trendelenburg position as opposed to neutral (supine) position

PRM Trendelenburg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankita Gupta: lead

Related Publications (4)

• Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.

  PMID: 9820719 BACKGROUND

• Ryu K, Choi W, Shim J, Song T. The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:55-60. doi: 10.1016/j.ejogrb.2016.11.014. Epub 2016 Nov 16.

  PMID: 27889667 BACKGROUND

• Kiyak H, Yilmaz G, Ay N. Semi-Fowler positioning in addition to the pulmonary recruitment manoeuvre reduces shoulder pain following gynaecologic laparoscopic surgery. Wideochir Inne Tech Maloinwazyjne. 2019 Dec;14(4):567-574. doi: 10.5114/wiitm.2019.84384. Epub 2019 Apr 11.

  PMID: 31908704 BACKGROUND

• Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.

  PMID: 18448749 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pneumoperitoneum

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Debbie Shim

CONTACT

502-561-7260; deborah.shim@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Fellowship Director, Urogynecology

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share