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Not yet recruiting NCT07631728

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

No phase Interventional Pain, Post-operative Pneumoperitoneum Urogynecologic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary recruitment maneuver, Trendelenburg position.
Who it may be relevant to
Registry conditions: Pain, Post-operative, Pneumoperitoneum, Urogynecologic Surgery. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Trendelenburg Positioning During Pulmonary Recruitment Breaths: A Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Pulmonary recruitment maneuver
    Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum
  • Procedure Trendelenburg position
    Trendelenburg position as opposed to neutral (supine) position

Primary outcome measures

  • Post-laparoscopy shoulder pain, 24 hour VAS [Time frame: 24 hours post-operatively]
Secondary outcome measures (10)
  • Post-laparoscopy shoulder pain, 72 hour VAS [Time frame: 72-hours post-operatively]
  • Pain Interference, 24 hour [Time frame: 24 hours post-operatively]
  • Pain Interference, 72 hour [Time frame: 72 hours post-operatively]
  • Total opioid use, 24 hr [Time frame: 24-hours postoperatively]
  • Total opioid use, 72 hr [Time frame: 72-hours postoperatively]
  • Time to flatus [Time frame: up to 72-hours postoperatively]
  • Nausea and Vomiting, 24 hour [Time frame: 24 hours post-operatively]
  • Nausea and Vomiting, 72 hour [Time frame: 72 hours post-operatively]
  • Gas & Bloating, 24 hour [Time frame: 24 hours post-operatively]
  • Gas & Bloating, 72 hour [Time frame: 72 hours post-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07631728 · 25.0897

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗