Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries

NCT04849468 | Unknown Phase 2 DMC

• 1 other identifier: IRB-2019-01-187-KFUH
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be carried out in order to test the effect of Intramuscular (IM) Diclofenac, administered as preemptive analgesic with minimal effective dose spinal anesthesia in perianal surgeries, on prolonging the time to first request for analgesic and lowering analgesic consumption. Investigators hypothesized that using IM Diclofenac in this surgery will postpone the time to first analgesic request and will decrease the consumption of post-operative analgesics. Our method includes dividing the patients into control and study groups and recording the first analgesic request and post-operative analgesic consumption after surgery and comparing the results.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• postoperative pain

  visual analogue scale

  up to 24 hours

• Time to first analgesia request

  first request of analgesia by the patient

  up to 24 hours

• total consumption of analgesia

  total consumption of tramadol in mg

  24 hours

Study Arms (2)

Diclofenac (D) group

ACTIVE COMPARATOR

Diclofenac (D) group which will receive 75 mg (3ml) intramuscular Diclofenac in a 5ml syringe in the holding area 30 minutes before spinal block

Drug: Declofenac

Saline (S) group

ACTIVE COMPARATOR

Saline (S) group which will receive 3ml intramuscular saline in a similar 5ml syringe in the holding area 30 minutes before spinal block

Drug: saline

Interventions

Declofenac DRUG

evaluating the preemptive effect of intramuscular declofenac on postoperative analgesia in patients undergoing perianal surgeries under saddle block

Diclofenac (D) group

saline DRUG

evaluating the preemptive effect of intramuscular saline on postoperative analgesia in patients undergoing perianal surgeries under saddle block as control

Saline (S) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I and II scheduled for elective outpatient perianal surgery in the lithotomy position (hemorrhoidectomy, fistulectomy)

You may not qualify if:

• contraindications to regional anesthesia, bleeding disorders, are morbidly obese, suffer from mental health problems, are on analgesic medication or psychotropic drugs, have a known history of allergy to amide local anesthetic drugs, if there is a language barrier, or if they are unwilling to participate

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd University Hospital

Khobar, Eastern Province, 34445, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Roshdi, professor

CONTACT

Roshdi R Youssef, M.D

CONTACT

00966502893485; rmetwalli@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The studied drugs will be prepared immediately before injection by an anesthesiologist blinded to the study methodology and will be administered by a second blinded anesthesiologist patients and assessor also will be unaware of the type of group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia consultant

Model Details: patients will be randomly allocated into two groups; Diclofenac (D) group which will receive 75 mg (3ml) IM Diclofenac in a 5ml syringe and Saline (S) group which will receive 3ml IM saline in a similar 5ml syringe

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2019
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

SA (1)