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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04849468
Enrollment
15
Registered
2021-04-19
Start date
2019-06-01
Completion date
2021-10-30
Last updated
2021-04-19

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

Conditions

Postoperative Pain

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

Interventions

DRUGDeclofenac

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

DRUGsaline

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

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative painup to 24 hoursvisual analogue scale
Time to first analgesia requestup to 24 hoursfirst request of analgesia by the patient
total consumption of analgesia24 hourstotal consumption of tramadol in mg

Countries

Saudi Arabia

Contacts

Primary ContactRoshdi, professor
Backup ContactRoshdi R Youssef, M.D
rmetwalli@yahoo.com00966502893485

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026