Comparison between pain control techniques, viz, injection of drug in the lower back, ultrasound-guided injection of drug in the upper back and patient-controlled pain management in breast cancer surgery

Comparison of the efficacy of intrathecal morphine, ultrasound-guided erector spinae plane block with PCA fentanyl in the control of post-operative pain after modified radical mastectomy: a randomized controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027756

Enrollment

Registered

2020-09-11

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

Interventions

Intervention1: Intrathecal morphine: Intrathecal Morphine: The patient will be placed in the sitting position, with the spine flexed. After identification of the landmarks, the back will be painted an

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-II patients scheduled to undergo elective modified radical mastectomy

Exclusion criteria

Exclusion criteria: 1) Patient refusal for regional techniques 2) All contra-indications to regional techniques: a) Local or systemic infection b) Known allergy to the study drugs c) Bleeding disorders d) Platelet count 3) BMI > 35 4) Inability to use PCA device post operatively

Design outcomes

Primary

Measure	Time frame
24-hour fentanyl consumptionTimepoint: From arrival in post-anesthesia care unit to 24 hours post-operatively	—

Secondary

Measure	Time frame
Incidence of adverse events (Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention)Timepoint: From arrival in post-anesthesia care unit to 24 hours post-operatively;Patient satisfaction scoreTimepoint: At 24 hours after operation;Post-operative pain parameters: 0-100mm Visual analogue scale (VAS) on abduction of ipsilateral arm above the headTimepoint: At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12 and 24 hours after operation.;Time to first analgesic requirementTimepoint: From arrival in post-anesthesia care unit to 24 hours post-operatively	—

Measure

Time frame

Incidence of adverse events (Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention)Timepoint: From arrival in post-anesthesia care unit to 24 hours post-operatively;Patient satisfaction scoreTimepoint: At 24 hours after operation;Post-operative pain parameters: 0-100mm Visual analogue scale (VAS) on abduction of ipsilateral arm above the headTimepoint: At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12 and 24 hours after operation.;Time to first analgesic requirementTimepoint: From arrival in post-anesthesia care unit to 24 hours post-operatively

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Countries

India

Contacts

Public ContactRebecca Lalnunfel Ralsun

All India Institute of Medical Sciences, New Delhi

drsrajeshwari@gmail.com9810079229

Outcome results

None listed

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