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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRM Trendelenburg | Active Comparator | PRM in Trendelenburg position (to 30 degrees or greatest degree patient can tolerate) with removal of tops of laparoscopic trocars |
|
| PRM Supine | Active Comparator | PRM in neutral position with removal of tops of laparoscopic trocars |
|
| Passive Supine | No Intervention | control group with passive evacuation of pneumoperitoneum: insufflation evacuation by removal of tops of laparoscopic trocars in neutral (supine) position |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary recruitment maneuver | Procedure | Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72-hours post-operatively |
| Pain Interference, 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debbie Shim | Contact | 502-561-7260 | deborah.shim@louisville.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9820719 | Background | 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. | |
| 27889667 | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Trendelenburg position | Procedure | Trendelenburg position as opposed to neutral (supine) position |
|
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). |
| 24 hours post-operatively |
| 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). | 72 hours post-operatively |
| Total opioid use, 24 hr | total opioid use measured by MME | 24-hours postoperatively |
| Total opioid use, 72 hr | total opioid use at 72-hr postoperatively measured by total MME | 72-hours postoperatively |
| Time to flatus | up to 72-hours postoperatively |
| Nausea and Vomiting, 24 hour | Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms). | 24 hours post-operatively |
| Nausea and Vomiting, 72 hour | Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms). | 72 hours post-operatively |
| Gas & Bloating, 24 hour | Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms). | 24 hours post-operatively |
| Gas & Bloating, 72 hour | Bloating measured by PROMIS Gas and Bloating 13a questionnaire. The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms). | 72 hours post-operatively |
| 31908704 | 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. |
| 18448749 | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |