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Fentanyl and Dexmedetomidine as adjuvant to bupivacaine in paravertebral block for postopertive analgesia

Effects of Fentanyl and Dexmedetomidine as adjuvant to bupivacaine in paravertebral block for postoperative analgesia in patients undergoing modified radical mastectomy: A prospective randomised double blind study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031164
Enrollment
60
Registered
2021-02-10
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: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Group BD: 20 ml of drug (18 ml bupivacaine (0.25%) + dexmedetomidine 1mcg/kg diluted to 2ml)to be administered in paravertebral block with with general anesthesia. Control Interventio

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I /II physical status. 2. Diagnosed cases of breast cancer. 3. Scheduled for elective modified radical mastectomy under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Bleeding disorders. 2. Allergy to amide-type local anesthetics. 3. Infection at the thoracic paravertebral injection site. 4. Pregnancy or breast feeding females. 5. Severe obesity (BMI >35kg/sqâ??m). 6. Psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
1. To assess the efficacy of dexmedetomidine and fentanyl as adjuvant to bupivacaine for postoperative pain management by paravertebral block. 2. Postoperative VAS score(on rest/movement). 3. Total rescue analgesia consumption. Timepoint: Pain assessment will be done in immediate post operative (0 min),30 min,1 hr,2 hr,4 hr,6 hr,12 hr and 24 hr.—

Secondary

MeasureTime frame
1. Intra operative hemodynamic parameters like changes in heart rate and blood pressure. 2. To compare the incidence of postoperative nausea and vomiting and any other side effects. Timepoint: 1st 24 hr postoperatively—

Countries

India

Contacts

Public ContactChetna Biswal

scb medical college,cuttack

drsidharth74@gmail.com943031992

Outcome results

None listed

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