Hernia, Hiatal, Pneumoperitoneum, Postoperative Pain, Shoulder Pain
Conditions
Brief summary
The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.
Interventions
PROCEDURELow pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
PROCEDUREStandard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Sponsors
Riverside University Health System Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing elective robot assisted hiatal hernia repair
Exclusion criteria
* patients less than 18 years of age * conversion to open surgery * BMI \> 40 * history of abdominoplasty * history of chronic pain and/or opioid dependence * history of COPD and/or supplemental oxygen use * pregnant patients * incarcerated patients * patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in post-operative shoulder pain | 1 week (on average) | Percentage reduction in post-operative shoulder pain from POD#0 to \ 1 week post-operative telephone appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative shoulder pain on POD #1 | 18 hours (on average) | Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \ 6-8AM) |
| Severity of postoperative shoulder pain at ~1 week | 1 week (on average) | Severity of postoperative shoulder pain at \ 1 week post-operative telephone appointment |
| Severity of postoperative shoulder pain at ~2 weeks post-op | 2 weeks (on average) | Severity of postoperative shoulder pain at \ 2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents |
| length of hospital stay | through study completion, an average of 2 years | length of hospital stay |
| Severity of postoperative shoulder pain on POD #0 | 6 hours (on average) | Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \ 7PM) |
| number of postoperative clinic visits related to shoulder pain management | through study completion, an average of 2 years | number of postoperative clinic visits related to shoulder pain management |
| discharge disposition | through study completion, an average of 2 years | discharge disposition (home, SNF, rehab, etc) |
| standard vs extended narcotic regimen | through study completion, an average of 2 years | standard vs extended (requiring refill) narcotic regimen |
| quality of life | 1 week (on average) | quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires |
| readmission rates for shoulder pain | through study completion, an average of 2 years | readmission rates for chief complaint of shoulder pain |
Countries
United States
Outcome results
None listed