Efficacy between nerve block and drug in patients undergoing gynecological oncological surgery

Combined Transmuscular Quadratus Lumborum block and sacral erector spine block versus intrathecal morphine for perioperative analgesia in patients undergoing open gynecological oncological surgery: An open label Prospective Randomized Non inferiority trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033449

Enrollment

Registered

2021-05-07

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: C579- Malignant neoplasm of female genital organ, unspecified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Combined Transmuscular quadratus lumborum block and sacral erector spinae plane block: Patient is positioned lateral with the side to be anesthetized turned upward and a low freq

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient undergoing open midline incision gynecological oncology surgery 2)patient giving consent for study

Exclusion criteria

Exclusion criteria: 1)patient refusing to participate 2)patients with history of local site infection 3)patients with history of allergy to local anaesthetic, induction agent and NSAIDS 4)patients with history of coagulopathy 5)patients on anticoagulant therapy for deranged INR or APTT value 6)patients with BMI more than 35 kg/ m2 7)patients with psychiatric illness 8)patients with deranged liver enzymes or serum creatinine more than 90mumol/lit

Design outcomes

Primary

Measure	Time frame
Postoperative 24hr morphine consumption as administered by intravenous patient controlled analgesia in patients undergoing open gynaecological oncological surgeryTimepoint: Postoperative 24hr morphine consumption as administered by intravenous patient controlled analgesia in patients undergoing open gynaecological oncological surgery	—

Secondary

Measure	Time frame
Cumulative analgesic consumption converted to oral morphine EquivalentTimepoint: 48hrs;Incidence of Postoperative nausea and vomitingTimepoint: Till 48hrs;Intraoperative fentanyl consumptionTimepoint: Intraoperative;Morphine consumptionTimepoint: 1-6, 6-12, 12-24hrs;Quality of recoveryTimepoint: 24 &48hrs;Sensory assessment at 30 mins by 3 point scaleTimepoint: 30 mins after block;Time to ambulateTimepoint: After recovery;Time to first activation of PCATimepoint: Time from block completion to first activation of PCA;Time to flatus and bladder a sensationTimepoint: After recovery;To observe complication such as pruritus, motor weakness, sedation, respiratory depression, hypotension, local anaesthetic systemic toxicityTimepoint: Till 48hrs;VAS score at rest and on movementTimepoint: O,2,4,6,12 24,30,36,42,48hrs	—

Measure

Time frame

Cumulative analgesic consumption converted to oral morphine EquivalentTimepoint: 48hrs;Incidence of Postoperative nausea and vomitingTimepoint: Till 48hrs;Intraoperative fentanyl consumptionTimepoint: Intraoperative;Morphine consumptionTimepoint: 1-6, 6-12, 12-24hrs;Quality of recoveryTimepoint: 24 &48hrs;Sensory assessment at 30 mins by 3 point scaleTimepoint: 30 mins after block;Time to ambulateTimepoint: After recovery;Time to first activation of PCATimepoint: Time from block completion to first activation of PCA;Time to flatus and bladder a sensationTimepoint: After recovery;To observe complication such as pruritus, motor weakness, sedation, respiratory depression, hypotension, local anaesthetic systemic toxicityTimepoint: Till 48hrs;VAS score at rest and on movementTimepoint: O,2,4,6,12 24,30,36,42,48hrs

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Countries

India

Contacts

Public ContactDebesh Bhoi

DEPARTMENT OF ANAESTHESIOLOGY , PAIN MEDICINE AND CRITICAL CARE , AIIMS ,NEW DELHI

debeshbhoi@gmail.com7042129428

Outcome results

None listed

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