MedDataX Logo

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

NCT ID: NCT02793323

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relieve Shoulder Pain After Laparoscopic Surgeries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Superficial cervical nerve block

Intervention Type OTHER

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

General anesthesia

Intervention Type 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

Intervention Type OTHER

100 ml IV saline

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.

Group Type PLACEBO_COMPARATOR

NSAID

Intervention Type OTHER

100 mg (100 ml) intravenous NSAIDs (Profenid)

General anesthesia

Intervention Type 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

Placebo superficial cervical nerve block

Intervention Type OTHER

Superficial cervical nerve block containing 5 ml saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Superficial cervical nerve block

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

Intervention Type OTHER

NSAID

100 mg (100 ml) intravenous NSAIDs (Profenid)

Intervention Type 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

Intervention Type OTHER

IV placebo

100 ml IV saline

Intervention Type OTHER

Placebo superficial cervical nerve block

Superficial cervical nerve block containing 5 ml saline

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zoher Naja, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Makassed General Hospital

Beirut, , Lebanon

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MakassedGH

Identifier Type: -

Identifier Source: org_study_id