Shoulder Pain
Conditions
Keywords
laparoscopy, shoulder pain, trendelenburg position
Brief summary
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.
Detailed description
A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, & 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.
Interventions
PROCEDURE20 degree Trendelenburg position
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female patients * Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2 * Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration. * Abdominal incisions less than 1.5 cm. * Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period. * Insufflation at a steady maximal flow of 30 l/min
Exclusion criteria
* Conversion to laparotomy. * Abdominal insufflation pressure more than 14 mm Hg. * Medical drug allergy to paracetamol, ketoprofen and/or tramadol. * Presence of gastro-esophageal reflux (GERD) * Pregnancy * Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT) * Obesity body mass index (BMI) greater than 40 * One day surgery patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain (12 hours) | 12 hours after laparoscopic surgery | Pain score (measured using a 0-10 numerical scale) at 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain | at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery | Pain score (measured using a 0-10 numerical scale) |
| Presence of nausea | at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery | Presence or absence of nausea (yes/no) |
| Severity of Nausea | at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery | Nausea score (measured using a 0-10 numerical scale) |
| Rescue pain medication | within first 24 hours after laparoscopic surgery | Time to first rescue pain medication (minutes) |
| Total rescue pain medication | within first 24 hours after laparoscopic surgery | Total rescue pain medication during first 24 hours |
| Patient satisfaction | 24 hours post laparoscopic surgery | Patient satisfaction with surgical experience (measured using a 0-10 numerical scale) |
Countries
Lebanon
Outcome results
None listed