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A clinical trial of comparing the effects of drugs namely Dexmedetomidine and Fentanyl when added to local anaesthetic solution used in injection around wound in in surgeries around anal canal in reducing pain after surgery

Completed
Conditions
Anal fissure, unspecified, (2) ICD-10 Condition: K603||Anal fistula, (3) ICD-10 Condition: K649||Unspecified hemorrhoids,
Registration Number
CTRI/2018/12/016807
Lead Sponsor
GOPALAKRISHNAN K
Brief Summary

This study is a randomized, double blind, parallel group, controlled, multiarm trial comparing the efficacy of dexmedetomidine  1.5micg/kg and fentanyl 2micg/ml when added to the local aneasthetic solution used for would infiltration done at the end of surgery in patients undergoing uncomplicated perianal surgeries to be conducted at Aarupadai Veedu medical college and Hospital, Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group. The secondary outcome measures will be reduction in total number of analgesics received over first 24 hrs and better defaecation score on the next day. Dexmedetomidine provides superior analgesia  than Fentanyl.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
75
Inclusion Criteria

Patients undergoing uncomplicated perianal surgeries like haemorrhoidectomy, fissure in ano and fistula in ano, ASA I & II, Normal BMI.

Exclusion Criteria

ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dexmedetomidine prolongs the postoperative analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration with12hours
Secondary Outcome Measures
NameTimeMethod
Total analgesics requirement in 24 hrs is reduced when dexmedetomidine is added to local anaesthetic solution. Addition of Fentanyl to local anaesthetic solution also reduces total analgesic requirement24hrs
pain perception at daefacation on next day is less intense.24 hours

Trial Locations

Locations (1)

Aarupadai Veedu Medical College and Hospital, Puducherry

🇮🇳

Pondicherry, PONDICHERRY, India

Aarupadai Veedu Medical College and Hospital, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Gopalakrishnan K
Principal investigator
9364450310
drkgpal73@gmail.com

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