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

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

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.

Study Overview

• Status: Completed
• Conditions: Relieve Shoulder Pain After Laparoscopic Surgeries
• Intervention / Treatment: Other: Superficial cervical nerve block; Other: General anesthesia; Other: IV placebo; Other: NSAID; Other: Placebo superficial cervical nerve block

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Makassed General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superficial cervical 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.	Other: Superficial cervical nerve block; A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.; Other: 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; Other: IV placebo; 100 ml IV saline
Placebo Comparator: 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.	Other: 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; Other: NSAID; 100 mg (100 ml) intravenous NSAIDs (Profenid); Other: Placebo superficial cervical nerve block; Superficial cervical nerve block containing 5 ml saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Makassed General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MakassedGH