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

Makassed General Hospital

Status: Completed

Conditions: Relieve Shoulder Pain After Laparoscopic Surgeries

Treatments: Other: Superficial cervical nerve block; Other: Placebo superficial cervical nerve block; Other: General anesthesia; Other: IV placebo; Other: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT02793323

MakassedGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Superficial cervical block

Experimental group

Description:

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.

Treatment:

Other: IV placebo

Other: General anesthesia

Other: Superficial cervical nerve block

NSAID

Placebo Comparator group

Description:

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.

Treatment:

Other: NSAID

Other: Placebo superficial cervical nerve block

Other: General anesthesia