The Prevention of Pain Associated With Rocuronium Injection

NCT02524743 | Completed Phase 4

• 1 other identifier: 02.04.2014/48
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether efficacy of different doses of lidocain and acetaminophen for the prevention of rocuronium injection pain and frequency of withdrawal movements during the general anesthesia induction period.

Conditions

Injection Site Irritation

Keywords

Rocuronium; lidocaine; acetaminophen,; pain; injection

Outcome Measures

Primary Outcomes (1)

• Change in intraoperative pain

  pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2)

  10 seconds

Secondary Outcomes (1)

• Change in postoperative pain

  24 hours

Study Arms (5)

Placebo (Group I)

PLACEBO COMPARATOR

For pretreatment the patients were administered IV 5ml normal saline. A 20-gauge catheter was inserted into a superficial vein on the dorsum of the patient's non- dominant hand. The lactated Ringer's solution was infused at 100 ml/h for five minutes, The infusion was stopped and the arm with the IV line was elevated for 15 seconds for gravity drainage of venous blood. The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator

Other: Placebo

Group II

ACTIVE COMPARATOR

For pretreatment the patients were administered IV acetaminophen 50 mg A 20-gauge catheter was inserted into a superficial vein on the dorsum of the patient's non- dominant hand. The lactated Ringer's solution was infused at 100 ml/h for five minutes, The infusion was stopped and the arm with the IV line was elevated for 15 seconds for gravity drainage of venous blood. The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator

Drug: acetaminophen

Group III

ACTIVE COMPARATOR

For pretreatment the patients were administered IV acetaminophen 25 mg. A 20-gauge catheter was inserted into a superficial vein on the dorsum of the patient's non- dominant hand. The lactated Ringer's solution was infused at 100 ml/h for five minutes, The infusion was stopped and the arm with the IV line was elevated for 15 seconds for gravity drainage of venous blood. The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator

Drug: acetaminophen

Group IV

ACTIVE COMPARATOR

For pretreatment the patients were administered IV lidocaine 20 mg The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator

Drug: Lidocaine

Group V

ACTIVE COMPARATOR

For pretreatment the patients were administered IV lidocaine 40 mg. A 20-gauge catheter was inserted into a superficial vein on the dorsum of the patient's non- dominant hand. The lactated Ringer's solution was infused at 100 ml/h for five minutes, The infusion was stopped and the arm with the IV line was elevated for 15 seconds for gravity drainage of venous blood. The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm. During and after the injection of rocuromum, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator

Drug: Lidocaine

Interventions

acetaminophen DRUG

The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated acetaminophen (50mg and 25 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.

Also known as: Parol, Perfalgan

Group II; Group III

Lidocaine DRUG

The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated lidocaine (20 mg and 40 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.

Also known as: Aritmal % 2, Jetmonal %10

Group IV; Group V

Placebo OTHER

The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated 5 ml iv normal saline before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.

Also known as: Saline

Placebo (Group I)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of ASA physical status I- II who were to undergo various elective operations.

You may not qualify if:

• Patients with chronic pain syndrome,
• Patients with neurologic deficits,
• Patients with thrombophlebitis,
• Patients with difficult venous access,
• Patients with allergy

Sponsors & Collaborators

• Suleyman Demirel University: lead

Related Publications (2)

• Steegers MA, Robertson EN. Pain on injection of rocuronium bromide. Anesth Analg. 1996 Jul;83(1):203. doi: 10.1097/00000539-199607000-00065. No abstract available.

  PMID: 8659757 BACKGROUND

• Kwak HJ, Kim JY, Kim YB, Min SK, Moon BK, Kim JY. Pharmacological prevention of rocuronium-induced injection pain or withdrawal movements: a meta-analysis. J Anesth. 2013 Oct;27(5):742-9. doi: 10.1007/s00540-013-1595-7. Epub 2013 Mar 22.

  PMID: 23519582 BACKGROUND

Related Links

• Springer

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Filiz Alkaya Solmaz

  Suleyman Demirel University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 17, 2015
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 17, 2015

Record last verified: 2015-08