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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

Comparison of analgesic efficacy of bupivacaine, bupivacaine and dexmedetomidine, and bupivacaine and Fentanyl in would infiltration technique in perianal surgeries: A prospective, randomized controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/12/016807
Enrollment
75
Registered
2018-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K602- Anal fissure, unspecified Health Condition 2: K603- Anal fistula Health Condition 3: K649- Unspecified hemorrhoids

Interventions

Intervention1: Wound infiltration with local anaesthetic agent bupivacaine and addition of drugs Dexmedetomidine and Fentanyl to the local anaesthetic solution: Wound infiltration with 15ml 0.5% bupiv

Sponsors

GOPALAKRISHNAN K
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Dexmedetomidine prolongs the postoperative analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration withTimepoint: 12hours—

Secondary

MeasureTime frame
pain perception at daefacation on next day is less intense.Timepoint: 24 hours;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 requirementTimepoint: 24hrs—

Countries

India

Contacts

Public ContactHaribabu V MD

Aarupadai Veedu Medical College and Hospital

saravanaharibabu@gmail.com9442369647

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026