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Effect of Adding Ondansetron and Magnesium to Lidocaine on postoperative pain in patients undergoing Upper Limb Surgery

Effect of Adding Ondansetron and Magnesium to Lidocaine for Intravenous Regional Anesthesia on Tourniquet pain and postoperative pain in patients undergoing Upper Limb Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016051425676N4
Enrollment
45
Registered
2016-11-06
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

injury of upper limb. Other injuries of upper limb, level unspecified

Interventions

Intervention 1: First intervention group, 3mg/kg of Lidocaine 0.5% diluted with saline plus 4 mg of Ondansetrone with a dose of 40 ml. Intervention 2: Second intervention group, 3mg/kg of Lidocaine 0.
Treatment - Drugs
Placebo
First intervention group, 3mg/kg of Lidocaine 0.5% diluted with saline plus 4 mg of Ondansetrone with a dose of 40 ml
Second intervention group, 3mg/kg of Lidocaine 0.5% diluted with Saline plus 5.7 ml of mgso4 20% with a dose of 40 ml
In control group, 3 mg/kg of Lidocaine 0.5% diluted With Saline with a dose of 40 ml

Sponsors

Vice Chancellor for research Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients 20 to 60 years old; Elective surgery of upper extremity fracture operation; with American Society of Anesthesiologists (ASA) physical status I or II; pleasure in entrance to study. Exclusion Criteria : Patients With Sickle Cell Anemia; History of hypersensitivity to drugs used in the study; History of Raynaud's Disease; Drug Abuse History; taking Nonsteroidal anti-inflammatory drugs(NSAID) or Sildindfil within last 24 hours; more than 1.5 hour long surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The timing of tourniquet pain. Timepoint: In 5, 10, 15, 20, 25 and 30 minutes intraoperation. Method of measurement: Score of pain in Visual analog scale (VAS).;Post operative pain. Timepoint: In 30 min and 2, 4 and 6 hours after opration. Method of measurement: Visual analogue Scales(VAS).

Secondary

MeasureTime frame
Post operation analgesic. Timepoint: In 30 min and 2, 4 and 6 Hours After Opration. Method of measurement: Patient file.;Onset of sensory and motor block. Timepoint: From the start of anesthetics injection. Method of measurement: Evaluate the patient’s response to needle hitting on surgical site and griping force.;Hemodynamic variables of the block. Timepoint: In 5, 10, 15 and 30 minutes intraoperation and 30 min, 2, 4, 6 hours after operation. Method of measurement: Monitoring system.;Recovery time of sensory block after opening the tourniquet. Timepoint: Every thirty seconds to return of sense in hand. Method of measurement: Short bevel needle.;Recovery time of motor block after opening the tourniquet. Timepoint: Every thirty seconds to complete movement of wrist. Method of measurement: Movement of wrist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shabnam Emami

Qazvin University of Medical Sciences

h_kayalha@yahoo.com+98 28 3332 0105

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026