Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420388
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-12
Brief Title:
2 Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy
Sponsor:
E-DA Hospital
Organization:
E-DA Hospital
Study Overview
Official Title:
Efficacy of 2 Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy A Randomized Double-Blind Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a randomized double-blind controlled trial evaluating the efficacy of 2 lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2 lidocaine gel or a non-anaesthetic lubricant gel control Pain scores using a visual analog scale VAS will be assessed at 12 and 24 hours and 2 3 and 7 days postoperatively Analgesic consumption will also be measured
Detailed Description:
Title Efficacy of 2 Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy A Randomized Double-Blind Controlled Trial Objective To assess the effect of 2 lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy
Study Design This study is a single-center randomized double-blind controlled trial Patients will be randomly assigned in a 11 ratio to receive either 2 lidocaine gel or a non-anaesthetic water-based lubricant gel control using a computer-generated randomization list The randomization will be stratified by hemorrhoid grade III or IV The study medication will be prepared by the hospital pharmacy and provided in identical pre-filled syringes to ensure blinding of participants and investigators
Intervention The intervention group will receive 5 mL of 2 lidocaine gel while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel The study medication will be applied to the perianal region three times per day for 7 days following surgery Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application
Outcome Assessment Postoperative pain will be assessed using a 100 mm visual analog scale VAS with 0 representing no pain and 100 representing the worst imaginable pain Pain scores will be recorded at 12 and 24 hours and 2 3 and 7 days after surgery Patients will also record their analgesic consumption in a diary including the type dose and frequency of analgesics used Postoperative complications such as bleeding infection or urinary retention will be assessed by the treating surgeon at each follow-up visit
Sample Size A sample size of 222 patients 111 per group was calculated based on a power of 80 a significance level of 005 and an expected difference in mean VAS scores of 15 mm between the groups with a standard deviation of 30 mm
Study Design This study is a single-center randomized double-blind controlled trial Patients will be randomly assigned in a 11 ratio to receive either 2 lidocaine gel or a non-anaesthetic water-based lubricant gel control using a computer-generated randomization list The randomization will be stratified by hemorrhoid grade III or IV The study medication will be prepared by the hospital pharmacy and provided in identical pre-filled syringes to ensure blinding of participants and investigators
Intervention The intervention group will receive 5 mL of 2 lidocaine gel while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel The study medication will be applied to the perianal region three times per day for 7 days following surgery Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application
Outcome Assessment Postoperative pain will be assessed using a 100 mm visual analog scale VAS with 0 representing no pain and 100 representing the worst imaginable pain Pain scores will be recorded at 12 and 24 hours and 2 3 and 7 days after surgery Patients will also record their analgesic consumption in a diary including the type dose and frequency of analgesics used Postoperative complications such as bleeding infection or urinary retention will be assessed by the treating surgeon at each follow-up visit
Sample Size A sample size of 222 patients 111 per group was calculated based on a power of 80 a significance level of 005 and an expected difference in mean VAS scores of 15 mm between the groups with a standard deviation of 30 mm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None