A clinical study comparing the effects of two drugs, Nalbuphine and Pentazocine, when used with spinal anaesthesia for operations below the waist

A Comparative study: Intrathecal Nalbuphine versus Intrathecal Pentazocine as adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under Subarachnoid block - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094695

Enrollment

Registered

2025-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nalbuphine: Nalbuphine acts as a kappa receptor agonist and ?-opioid receptor antagonist, offering significant analgesia with minimal side effects such as respiratory depression, prurit

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving informed consent ASA grade one or two Patients scheduled for elective lower abdominal, perineal, or lower limb surgeries

Exclusion criteria

Exclusion criteria: Patients not willing to participate in the study ASA grade three and above Patients with uncontrolled or labile hypertension, Diabetes Mellitus, psychiatric disorders, history of chronic low back pain, evidence of hepatic or renal dysfunction, known hypersensitivity to local anaesthetics or opioids

Design outcomes

Primary

Measure	Time frame
To compare the duration of postoperative analgesia provided by intrathecal nalbuphine and pentazocine when used as adjuvants to 0.5% hyperbaric bupivacaineTimepoint: time(in minutes) to first rescue analgesia	—

Secondary

Measure	Time frame
To compare the onset time and duration of sensory and motor block between the two adjuvant groups. Timepoint: Onset of sensory block: Time interval (in minutes) from the completion of intrathecal drug injection to the complete loss of pinprick sensation at the surgical dermatome level Onset of motor block: Time (in minutes) from intrathecal injection to the patient?s inability to lift the extended lower limb against gravity Duration: Time(in minutes) from intrathecal injection to the first patient-reported pain score of VAS more than 3;To assess and compare intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure) in both groups. Timepoint: Intraoperative parameters: Every 10 minutes Postoperative parameters: 0, 6, 12 and 24 hours;To evaluate the incidence of adverse effects such as nausea, vomiting, hypotension, bradycardia, pruritus, and respiratory depression associated with each adjuvant.Timepoint: Noted till 24 hours postoperatively	—

Measure

Time frame

To compare the onset time and duration of sensory and motor block between the two adjuvant groups. Timepoint: Onset of sensory block: Time interval (in minutes) from the completion of intrathecal drug injection to the complete loss of pinprick sensation at the surgical dermatome level Onset of motor block: Time (in minutes) from intrathecal injection to the patient?s inability to lift the extended lower limb against gravity Duration: Time(in minutes) from intrathecal injection to the first patient-reported pain score of VAS more than 3;To assess and compare intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure) in both groups. Timepoint: Intraoperative parameters: Every 10 minutes Postoperative parameters: 0, 6, 12 and 24 hours;To evaluate the incidence of adverse effects such as nausea, vomiting, hypotension, bradycardia, pruritus, and respiratory depression associated with each adjuvant.Timepoint: Noted till 24 hours postoperatively

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Countries

India

Contacts

Public ContactShital K Madavi

Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research

msheetal025@gmail.com9921838568

Outcome results

None listed

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