Superficial Cervical Nerve Block vs NSAIDs for the Relief of Shoulder Pain After Laparoscopic Surgeries

Study Overview
=================
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.

Official Title
-----------------
Superficial Cervical Nerve Block Versus NSAIDs for the Relief of Shoulder Tip Pain After Laparoscopic Surgeries

Conditions
-----------------
Relieve Shoulder Pain After Laparoscopic Surgeries

Intervention / Treatment
-----------------
* Other: Superficial cervical nerve block
* Other: NSAID
* Other: General anesthesia
* Other: IV placebo
* Other: Placebo superficial cervical nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superficial cervical block<br>Patients will receive superficial cervical nerve block in which we inject 5 ml of local anaesthetic mixture. Each 17 ml of the mixture contain: 6 ml lidocaine 2%, 6 ml lidocaine 2% with adrenaline 5 µg/ml, and 5 ml bupivacaine 0.5. Patients will also receive 100 ml IV saline. | Other: Superficial cervical nerve block<br>* A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.<br>Other: General anesthesia<br>* 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<br>Other: IV placebo<br>* 100 ml IV saline<br>|
| Placebo Comparator: NSAID<br>Patients will receive 100 mg (100 ml) IV NSAIDs (Profenid) before induction of anesthesia. Superficial cervical nerve block containing 5 ml placebo will be performed. | Other: NSAID<br>* 100 mg (100 ml) intravenous NSAIDs (Profenid)<br>Other: General anesthesia<br>* 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<br>Other: Placebo superficial cervical nerve block<br>* Superficial cervical nerve block containing 5 ml saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores assessed through the Visual Analogue Scale (VAS) |  | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving analgesics |  | 48 hours postoperatively | 
| Length of hospital stay |  | An average of 24 hours |