Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Declofenac
saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists physical status I and II scheduled for elective outpatient perianal surgery in the lithotomy position (hemorrhoidectomy, fistulectomy)
Exclusion Criteria:
- 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
Sites / Locations
- King Fahd University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Diclofenac (D) group
Saline (S) group
Arm Description
Diclofenac (D) group which will receive 75 mg (3ml) intramuscular Diclofenac in a 5ml syringe in the holding area 30 minutes before spinal block
Saline (S) group which will receive 3ml intramuscular saline in a similar 5ml syringe in the holding area 30 minutes before spinal block
Outcomes
Primary Outcome Measures
postoperative pain
visual analogue scale
Time to first analgesia request
first request of analgesia by the patient
total consumption of analgesia
total consumption of tramadol in mg
Secondary Outcome Measures
Full Information
NCT ID
NCT04849468
First Posted
April 8, 2021
Last Updated
April 16, 2021
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT04849468
Brief Title
Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries
Official Title
Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Effective control of post-operative pain is an issue that has been repeatedly emphasized and has received an increasing amount of attention in the past few years (1, 2). Opioids, despite their side effects, are still the main cornerstone in managing acute postoperative pain (3). Preemptive analgesia refers to the administration of effective analgesia prior to surgical trauma. The main mechanism of preemptive analgesia is desensitization of the central nervous system and prevention of pain before its onset. (3). Non-opioid preemptive analgesics are commonly used to increase analgesic efficacy and patient satisfaction as well as to reduce opioid consumption and side effects. Saddle anesthesia is a selective spinal anesthesia that is commonly used for perianal surgeries (4-7).
Investigators previously performed a prospective up-down sequential allocation study to evaluate the minimum effective dose of hyperbaric bupivacaine that is needed for inducing a satisfactory and reliable saddle block for perianal surgeries that was restricted to the most caudal spinal nerve roots (S4-coccygeal) that supply the perianal region (8). Although the block produced no motor block in the lower limbs (thus allowing early ambulation), rapid sensory recovery resulted in early request of analgesia and increased opioid consumption. In this prospective, randomized, double blinded, placebo controlled clinical trial, Investigators hypothesize that a single dose of IM diclofenac administered before spinal anesthesia, will decrease postoperative pain, and delay and reduce postoperative analgesic requirement in patients undergoing minor perianal surgeries under minimal effective-dose bupivacaine saddle block
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac (D) group
Arm Type
Active Comparator
Arm Description
Diclofenac (D) group which will receive 75 mg (3ml) intramuscular Diclofenac in a 5ml syringe in the holding area 30 minutes before spinal block
Arm Title
Saline (S) group
Arm Type
Active Comparator
Arm Description
Saline (S) group which will receive 3ml intramuscular saline in a similar 5ml syringe in the holding area 30 minutes before spinal block
Intervention Type
Drug
Intervention Name(s)
Declofenac
Intervention Description
evaluating the preemptive effect of intramuscular declofenac on postoperative analgesia in patients undergoing perianal surgeries under saddle block
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
evaluating the preemptive effect of intramuscular saline on postoperative analgesia in patients undergoing perianal surgeries under saddle block as control
Primary Outcome Measure Information:
Title
postoperative pain
Description
visual analogue scale
Time Frame
up to 24 hours
Title
Time to first analgesia request
Description
first request of analgesia by the patient
Time Frame
up to 24 hours
Title
total consumption of analgesia
Description
total consumption of tramadol in mg
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists physical status I and II scheduled for elective outpatient perianal surgery in the lithotomy position (hemorrhoidectomy, fistulectomy)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roshdi, professor
First Name & Middle Initial & Last Name or Official Title & Degree
Roshdi R Youssef, M.D
Phone
00966502893485
Email
rmetwalli@yahoo.com
Facility Information:
Facility Name
King Fahd University Hospital
City
Khobar
State/Province
Eastern
ZIP/Postal Code
34445
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hitham Mohammed consultant, MD
Phone
009660138966666
Ext
1486
Email
HIMelsayed@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Alaa Mohammed Consultant, MD
Phone
009660138966666
Ext
1486
Email
akhedr@iau.edu.sa
12. IPD Sharing Statement
Learn more about this trial
Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries
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