Pain, Post-operative, Pneumoperitoneum, Urogynecologic Surgery
Conditions
Keywords
Trendelenburg, pneumoperitoneum, post-laparoscopy shoulder pain, post-laparoscopy pain, gynecologic surgery
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.
Interventions
PROCEDUREPulmonary recruitment maneuver
Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum
PROCEDURETrendelenburg position
Trendelenburg position as opposed to neutral (supine) position
Sponsors
Ankita Gupta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-laparoscopy shoulder pain, 24 hour VAS | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-laparoscopy shoulder pain, 72 hour VAS | 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. |
| Pain Interference, 24 hour | 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). |
| Pain Interference, 72 hour | 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). |
| Total opioid use, 24 hr | 24-hours postoperatively | total opioid use measured by MME |
| Total opioid use, 72 hr | 72-hours postoperatively | total opioid use at 72-hr postoperatively measured by total MME |
| Time to flatus | up to 72-hours postoperatively | — |
| Nausea and Vomiting, 24 hour | 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). |
| Nausea and Vomiting, 72 hour | 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). |
| Gas & Bloating, 24 hour | 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). |
| Gas & Bloating, 72 hour | 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). |
Contacts
CONTACTDebbie Shim
Outcome results
None listed