A Study of Pudendal Nerve Block ( Inferior Rectal Branch) for Post - Haemorrhoidectomy Pain

Not Applicable

Completed

• Conditions: Post Haemorrhoidectomy Pain

• Registration Number: CTRI/2018/05/013866
• Lead Sponsor: Sree Gokulam Medical College And Research Foundation

Brief Summary

A study was conducted to compare the duration of post-operative analgesia in patients undergoing haemorrhoidectomy who are given pudendal nerve block with either Clonidine or Dexmedetomidine alongwith local anaesthetic Bupivacaine in the operation theatre of Sree Gokulam Medical College and Research Foundation, Venjaramoodu, Trivandrum, Kerala. 60 patients were randomly divided into two groups of 30 each -- group C underwent pudendal block with 20ml of 0.25% Bupivacaine with Clonidine 1mcg / kg as additive  and group D underwent pudendal block with 20ml of 0.25% Bupivacaine with Dexmedetomidine 1mcg/kg as additive . Complications like sedation, bradycardia and hypotension were also studied.  The data was entered in excel and analysed using SPSS 20.0 and compared using t test and chi square test. There was significant difference in the duration of post-operative analgesia between the two groups. The duration of analgesia in group C was 761 +/\_ 19.1 minutes while in group D it was  1184.57 +/\_ 151.374 minutes. In pudendal nerve block, addition of Dexmeditomidine as an adjuvant to 0.25% Bupivacaine prolongs the duration of post-operative analgesia and is not associated with any major side effects. Both drugs have an added advantage of conscious sedation and haemodynamic stability, making them potential adjuvants for nerve blocks.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Study Completion: 2016-03-24
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

BMI<30 Normal coagulation parameters and platelet count(>100000) No systemic infection.

Exclusion Criteria

BMI>30 Severe liver renal or cardiac disease Allergy or contraindications to any of the study drugs Previous surgery in the anal canal Pain or chronic analgesic administration in the preoperative period Abnormal coagulation parameters and platelet count(<100000) Systemic infection Patient requesting general anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of post-operative analgesia	Post operative monitoring for 24 hours

Secondary Outcome Measures

Name	Time	Method
Post operative haemodynamic stability	1,5,10,30,60,120,180,240,360,480,600,720 min after completion of injection
Sedation	Every 30 minutes for 24 hours during the postoperative period

Trial Locations

Locations (1)

Sree Gokulam Medical College And Research Foundation; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Gokulam Medical College And Research Foundation

🇮🇳Thiruvananthapuram, KERALA, India

Dr Madhu Velayudhen

Principal investigator

9400369133

madhuvelayuden@gmail.com