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

Primary Purpose

Relieve Shoulder Pain After Laparoscopic Surgeries

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Superficial cervical nerve block
NSAID
General anesthesia
IV placebo
Placebo superficial cervical nerve block
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relieve Shoulder Pain After Laparoscopic Surgeries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Superficial cervical block

NSAID

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain scores assessed through the Visual Analogue Scale (VAS)

Secondary Outcome Measures

Number of patients receiving analgesics
Length of hospital stay

Full Information

First Posted
May 30, 2016
Last Updated
November 2, 2017
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02793323
Brief Title
Superficial Cervical Nerve Block vs NSAIDs for the Relief of Shoulder Pain After Laparoscopic Surgeries
Official Title
Superficial Cervical Nerve Block Versus NSAIDs for the Relief of Shoulder Tip Pain After Laparoscopic Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relieve Shoulder Pain After Laparoscopic Surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Superficial cervical block
Arm Type
Experimental
Arm Description
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.
Arm Title
NSAID
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Superficial cervical nerve block
Intervention Description
A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.
Intervention Type
Other
Intervention Name(s)
NSAID
Intervention Description
100 mg (100 ml) intravenous NSAIDs (Profenid)
Intervention Type
Other
Intervention Name(s)
General anesthesia
Intervention Description
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
Intervention Name(s)
IV placebo
Intervention Description
100 ml IV saline
Intervention Type
Other
Intervention Name(s)
Placebo superficial cervical nerve block
Intervention Description
Superficial cervical nerve block containing 5 ml saline
Primary Outcome Measure Information:
Title
Pain scores assessed through the Visual Analogue Scale (VAS)
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Number of patients receiving analgesics
Time Frame
48 hours postoperatively
Title
Length of hospital stay
Time Frame
An average of 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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

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