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A clinical trial to study the effectiveness of pre-emptive tapentadol with block in patients undergoing breast surgery.

Effects of pre-emptive Tapentadol combined with ipsilateral Pectoral nerve block on postoperative analgesia in patients undergoing modified radical mastectomy: a prospective, randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027509
Enrollment
72
Registered
2020-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: tapentadol: 100 mg of Extended Release tapentadol, 1 hr prior to surgery. Control Intervention1: placebo: similar looking dummy capsule Control Intervention2: placebo: similar looking d

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (Age >18 years and 2. Patients who can understand and provide a valid consent for the procedure and also can understand and are willing to report the pain using VAS score.

Exclusion criteria

Exclusion criteria: Patients with 1. Chronic pain syndromes and on daily analgesics 2. Abnormal renal or liver function 3. Known psychiatric disorder receiving monoamine oxidase Inhibitors, tricyclic antidepressants or serotonin-norepinephrine reuptake inhibitors 4. COPD, asthma or other respiratory ailments 5. Infection at injection site 6. Bilateral breast surgeries 7. Opioid tolerance or dependence 8. Allergic to the study drug (tapentadol& bupivacaine)

Design outcomes

Primary

MeasureTime frame
1.To compare mean pain-free duration in patients receiving 100mg of extended-release (ER) preemptive tapentadol and in the control group following modified radical mastectomyTimepoint: 2hrs, 4hrs, 6hrs, 12hrs, 24hrs following surgery.—

Secondary

MeasureTime frame
2. To compare the mean visual analog scale (VAS) score at 2hrs, 4hrs, 6hrs, 12hrs, and 24hrs 3. To compare the total dose of rescue analgesia required in the first 24hrs 4. To compare the total dose of intraoperative fentanyl used 5. To assess the incidence of complications (postoperative retching, nausea, vomiting (PONV), pruritus and dizziness) in both groups in the first 24hrs Timepoint: 2. To compare the mean visual analog scale (VAS) score at 2hrs, 4hrs, 6hrs, 12hrs, and 24hrs 3. To compare the total dose of rescue analgesia required in the first 24hrs 4. To compare the total dose of intraoperative fentanyl used 5. To assess the incidence of complications (postoperative retching, nausea, vomiting (PONV), pruritus and dizziness) in both groups in the first 24hrs—

Countries

India

Contacts

Public ContactDr Sritam Swarup Jena

AIIMS,Bhubaneswar

sritamswarup@gmail.com8951614718

Outcome results

None listed

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