Relieve Shoulder Pain After Laparoscopic Surgeries
Conditions
Brief summary
Shoulder pain is frequently mentioned in recent literature following laparoscopic operations. Several pain relief strategies have been proposed to decrease shoulder tip pain post laparoscopic surgeries. This study will be conducted to compare the Superficial cervical nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.
Detailed description
The study will be conducted in the operating room and post anesthesia care unit (PACU) at Makassed General Hospital. This is a prospective double blind randomized clinical trial that will be conducted between June 2016 and June 2017 at Makassed General Hospital. Following the Institutional Review Board (IRB) approval, written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 groups. Group I will receive superficial cervical nerve block and intravenous saline. Group II will receive saline superficial cervical block and intravenous NSAID (Profenid). All patients will receive general anesthesia. General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. Any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.
Interventions
OTHERSuperficial cervical nerve block
A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.
OTHERNSAID
100 mg (100 ml) intravenous NSAIDs (Profenid)
OTHERGeneral anesthesia
General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen
OTHERIV placebo
100 ml IV saline
OTHERPlacebo superficial cervical nerve block
Superficial cervical nerve block containing 5 ml saline
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic: cholecystectomy, sleeve gastrectomy, mini bypass surgery, gastric plication
Exclusion criteria
* Patients with kidney disease (ACUTE OR CHRONIC) * Patients with allergy to any medication used throughout the research * Patients with gastroesophageal reflux disease (GERD), peptic ulcer or duodenal ulcer disease * Patients with shoulder neck pain or complications pre-operatively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scores assessed through the Visual Analogue Scale (VAS) | 48 hours postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients receiving analgesics | 48 hours postoperatively |
| Length of hospital stay | An average of 24 hours |
Countries
Lebanon
Outcome results
None listed