Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000850471
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Pudendal Nerve Block in reducing Post-Op Pain after Proctological Interventions in patients aged 18 to 70 years old
Scientific title
Effectiveness of Pudendal Nerve Block in reducing Post-Op Pain after Proctological Interventions in patients aged 18 to 70 years old
Secondary ID [1] 314009 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhoids 336673 0
Perianal Fistula 337411 0
Anesthesia 337412 0
Condition category
Condition code
Surgery 333167 333167 0 0
Other surgery
Anaesthesiology 333791 333791 0 0
Pain management
Oral and Gastrointestinal 333792 333792 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were draped using aseptic technique in the lithotomy position and scrubbed. After the completion of surgery whether for hemorrhoids or anal fistula, the anatomical landmarks were identified for Pudendal Nerve block for Group A patients. The agents used for the block were 5 ml of 2% Lignocaine mixed with 10 ml of 0.5% Bupivacaine. Trans perineal approach was used for the block. A 25 Gauge, 10 cm, short bevel Spinal Needle was inserted perpendicular to the skin medial to the ischial tuberosity and advanced in the sagittal plane. The confirmation of needle position in proximity of the Pudendal nerve was made upon the slight contraction of the anal sphincter. The anesthetic agents were then injected. Patients were later on shifted to the post operative ward and monitored for pain for 8 hours post surgery. Group B "control" group did not receive any anesthetic. Direct observation and Numeric rating scale was used for pain levels measurement.
Intervention code [1] 330591 0
Treatment: Drugs
Comparator / control treatment
Group B "control" group did not receive any anesthetic. Direct observation and Numeric rating scale was used for pain levels measurement.
Control group
Active

Outcomes
Primary outcome [1] 340802 0
Post operative pain
Timepoint [1] 340802 0
4 and 8 hours post operative time
Primary outcome [2] 340803 0
Early mobilization post surgery
Timepoint [2] 340803 0
4 and 8 hours post operative
Secondary outcome [1] 445109 0
Need for additional analgesia
Timepoint [1] 445109 0
After discharge review of documents

Eligibility
Key inclusion criteria
All patients of ages 18 to 70 years, who were declared fit in American Association of Anesthesiologists (ASA) class I or II, for the proctological surgery including hemorrhoidectomy or fistulectomy were enrolled in the trial.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
96
Accrual to date
46
Final
Recruitment outside Australia
Country [1] 26904 0
Pakistan
State/province [1] 26904 0
Punjab

Funding & Sponsors
Funding source category [1] 318923 0
Hospital
Name [1] 318923 0
Combined Military Hospital Tamiz ud din road Rawalpindi Pakistan 46000
Country [1] 318923 0
Pakistan
Primary sponsor type
Hospital
Name
Combined Military Hospital Tamiz ud din road Rawalpindi Pakistan 46000
Address
Country
Pakistan
Secondary sponsor category [1] 321392 0
None
Name [1] 321392 0
Address [1] 321392 0
Country [1] 321392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317068 0
Hospital ethics committee Combined Military Hospital Tamiz
Ethics committee address [1] 317068 0
Ethics committee country [1] 317068 0
Pakistan
Date submitted for ethics approval [1] 317068 0
31/05/2024
Approval date [1] 317068 0
24/07/2024
Ethics approval number [1] 317068 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139894 0
Dr Hamza Shakeel
Address 139894 0
Combined Military Hospital, Tamiz Ud Din Road, CMH Road, Rawalpindi-Pakistan 46000
Country 139894 0
Pakistan
Phone 139894 0
+920519270163
Fax 139894 0
Email 139894 0
[email protected]
Contact person for public queries
Name 139895 0
Dr Hamza Shakeel
Address 139895 0
Combined Military Hospital, Tamiz Ud Din Road, CMH Road, Rawalpindi-Pakistan 46000
Country 139895 0
Pakistan
Phone 139895 0
+920519270163
Fax 139895 0
Email 139895 0
[email protected]
Contact person for scientific queries
Name 139896 0
Hamza Shakeel
Address 139896 0
Combined Military Hospital, Tamiz Ud Din Road, CMH Road, Rawalpindi-Pakistan 46000
Country 139896 0
Pakistan
Phone 139896 0
+920519270163
Fax 139896 0
Email 139896 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.