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

Not Applicable

Completed

• Conditions: Relieve Shoulder Pain After Laparoscopic Surgeries
• Interventions: Other: Superficial cervical nerve block; Other: NSAID; Other: General anesthesia; Other: IV placebo; Other: Placebo superficial cervical nerve block

• Registration Number: NCT02793323
• Lead Sponsor: Makassed General Hospital

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.

Study Timeline

• Study First Submitted: 2016-05-30
• Study Start: 2016-06-01
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superficial cervical block	Superficial cervical nerve block	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.
Superficial cervical block	General anesthesia	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.
Superficial cervical block	IV placebo	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.
NSAID	Placebo superficial cervical nerve block	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.
NSAID	NSAID	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.
NSAID	General anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Pain scores assessed through the Visual Analogue Scale (VAS)	48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Number of patients receiving analgesics	48 hours postoperatively
Length of hospital stay	An average of 24 hours

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon