IVRA: Intravenous Regional Analgesia

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05543785

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.

Condition or Disease	Intervention/Treatment	Phase
Ketorolac Analgesia	Drug: Ketorolac Drug: normal saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

An anesthetist, not involved in the study, was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drug

Primary Purpose:

Prevention

Official Title:

Intravenous Regional Analgesia With Ketorolac; Does it Work? A Prospective Randomized Double-blinded Controlled Study

Anticipated Study Start Date :

Oct 31, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control received 10 ml normal saline	Drug: normal saline After conformation of circulatory isolation of the operated limb by the inflated tourniquet, 10 ml normal saline will be injected
Active Comparator: ketorolac received 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 10 ml	Drug: Ketorolac After conformation of circulatory isolation of the operated limb by the inflated tourniquet, 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 10 ml will be injected

Arm

Intervention/Treatment

Placebo Comparator: control

received 10 ml normal saline

Drug: normal saline

After conformation of circulatory isolation of the operated limb by the inflated tourniquet, 10 ml normal saline will be injected

Active Comparator: ketorolac

received 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 10 ml

Drug: Ketorolac

After conformation of circulatory isolation of the operated limb by the inflated tourniquet, 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 10 ml will be injected

Outcome Measures

Primary Outcome Measures

The postoperative analgesic duration [within 24 hours after the surgery]
the time measured from tourniquet inflation to the first request of analgesia by the patient

Secondary Outcome Measures

Postoperative pain at rest [within the first 24 hours after surgery]
10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain
Total postoperative analgesic consumption [within the first 24 hours after surgery]
Patients with visual analog scale more than 3 will receive postoperative analgesic

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists physical status I or II
Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia

Exclusion Criteria:

Pregnant females
Body mass index ≥ 35 kg/m2
Allergy to ketorolac
Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias
Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides
Edema in the operated limb grade ≥ 3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals	Mansoura		Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Study Director: Maha AboZeid, MD, Mansoura University, Faculty of Medicine -

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University

ClinicalTrials.gov Identifier:

NCT05543785

Other Study ID Numbers:

Intravenous regional analgesia

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Agnosia

Ketorolac

Study Results

No Results Posted as of Sep 16, 2022