Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02524743
Other study ID # 02.04.2014/48
Secondary ID
Status Completed
Phase Phase 4
First received August 5, 2015
Last updated August 13, 2015
Start date May 2014
Est. completion date October 2014

Study information

Verified date August 2015
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device InstitutionTurkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

The study was conducted on 150 patients aged 18- 70 years of ASA (American Society of Anesthesiologists) physical status I- II who were to undergo various elective operations. None of the patients was premedicated before the operation. The patients were monitored with three derivation electrocardiogram, non- invasive arterial pressure, and pulse oximeter.

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 and the patients were pretreated by either lidocaine (20 mg and 40 mg IV) or acetaminophen (50mg and 25 mg IV) before the injection of rocuronium. Some patients received 5 ml normal saline. The patients were randomly assigned to five groups. For pretreatment the patients were administered 5 ml normal saline in Group I (Control); acetaminophen 50mg in Group II, acetaminophen 25 mg in Group III, lidocaine 20 mg in Group IV and lidocaine 40mg in Group V, diluted into 5 mL of saline IV. The occlusion was released after 120 s and 0.6 mg/kg of rocuronium 1% was injected IV over 5 seconds. During and after the injection of rocuronium, pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) by the study-blinded investigator. 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.

Table 1: Four Point Scala (TEST 1) Degree of pain Response Pain score

1. None: Negative response to questioning: 0

2. Mild: Pain reported in response to questioning only, without any behavioral signs: 1

3. Moderate: Pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning: 2

4. Severe: Strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears : 3

Table 2: Evaluation Of Withdrawal Movements During Rocuronium Injection ( TEST2) Pain Score Response

1. No response

2. Movement at wrist only

3. Movement/ withdrawal involving arm only (elbow/ shoulder)

4. Generalized response ( movement/ withdrawal in more than one extremity, cough or breath holding)


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 18- 70 years of ASA physical status I- II who were to undergo various elective operations.

Exclusion Criteria:

- Patients with chronic pain syndrome,

- Patients with neurologic deficits,

- Patients with thrombophlebitis,

- Patients with difficult venous access,

- Patients with allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
acetaminophen
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.
Lidocaine
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.
Other:
Placebo
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

References & Publications (2)

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. Review. — View Citation

Steegers MA, Robertson EN. Pain on injection of rocuronium bromide. Anesth Analg. 1996 Jul;83(1):203. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in intraoperative pain pain was graded with four point scale (TEST 1) and withdrawal movement was evaluated (TEST 2) 10 seconds Yes
Secondary Change in postoperative pain Twenty-four hours after the operation, the injection site was checked for any complications, such as pain, swelling or allergic reaction 24 hours Yes
See also
  Status Clinical Trial Phase
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Not yet recruiting NCT05109000 - Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline Phase 4
Completed NCT04582032 - Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain N/A
Completed NCT04673500 - Assessment of Pain on Propofol Injection. N/A
Recruiting NCT05378113 - Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial Phase 2
Completed NCT01824758 - Effect of Esmolol on Pain Due to Rocuronium Phase 4
Completed NCT04555980 - Warm Patch Decrease Propofol Injection Pain N/A
Completed NCT04436666 - Virtual Reality, Ice Application and Self-injection and Self-test Fair, Pain and State Anxiety N/A
Recruiting NCT03420560 - A Warmer Temperature Decrease Propofol Injection Pain N/A
Completed NCT05225610 - Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper GIT Endoscopy N/A
Recruiting NCT05221333 - Sorrel 25R Injector - Sorrel Clinical Study Protocol N/A
Recruiting NCT05269823 - Topical Ice-therapy for Intravitreal Injections N/A

External Links