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

Relieve Shoulder Pain After Laparoscopic Surgeries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793323
• Other study ID #: MakassedGH
• Status: Completed
• Phase: N/A
• First received: May 30, 2016
• Last updated: November 2, 2017
• Start date: June 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: November 2017
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Relieve Shoulder Pain After Laparoscopic Surgeries
• Shoulder Pain

Intervention

Other:
• Superficial cervical nerve block
A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.
• NSAID
100 mg (100 ml) intravenous NSAIDs (Profenid)
• 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
• IV placebo
100 ml IV saline
• Placebo superficial cervical nerve block
Superficial cervical nerve block containing 5 ml saline

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores assessed through the Visual Analogue Scale (VAS)		48 hours postoperatively
Secondary	Number of patients receiving analgesics		48 hours postoperatively
Secondary	Length of hospital stay		An average of 24 hours