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Completed

NCT Number: NCT02793323

Superficial Cervical Nerve Block vs NSAIDs for the Relief of Shoulder 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.

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Key information

Conditions

Relieve Shoulder Pain After Laparoscopic Surgeries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superficial cervical nerve block

Other

A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.

NSAID

Other

100 mg (100 ml) intravenous NSAIDs (Profenid)

General anesthesia

Other

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

Other

100 ml IV saline

Placebo superficial cervical nerve block

Other

Superficial cervical nerve block containing 5 ml saline

Primary outcomes

  1. Pain scores assessed through the Visual Analogue Scale (VAS)

    Time frame: 48 hours postoperatively

Secondary outcomes

  1. Number of patients receiving analgesics

    Time frame: 48 hours postoperatively

  2. Length of hospital stay

    Time frame: An average of 24 hours

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.