Clinical study of two drugs, Ketamine and pentazocine, both pain killers mixed with bupivacaine, a local anesthestic to numb the operative site by spinal injection and compares changes in blood pressure, heart rate during, pain free time after surgery in patients advised for lower leg surgeries.

To compare the hemodynamic effects, duration and efficacy of analgesia of intrathecal ketamine versus pentazocine as adjuvant to subarachnoid block in lower limb surgeries. - nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026690

Enrollment

Registered

2020-07-20

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: M849- Disorder of continuity of bone, unspecified

Interventions

Intervention1: Pentazocine with 0.5 % Bupivacaine(Heavy) in spinal anesthesia: Single dose, 15 mg (0.5 ml) Pentazocine added to 15 mg (3.0ml) 0.5% Bupivacaine (Heavy) given intrathecal route of admini

Eligibility

Inclusion criteria

Inclusion criteria: 90 adult patients All American Society of Anesthesiologists Grade I and II

Exclusion criteria

Exclusion criteria: 1. Not willing to participate in the study 2. Pregnancy 3.Coagulation abnormalities 4. Neurological Disorders 5. Signs of Sepsis 6. Past Spinal injury,Surgery,Spinal Deformity 7. Morbid Obesity 8. Anticipated difficulty in Regional Anesthesia 9. Any allergies to drugs 10. Life threatening illness

Design outcomes

Primary

Measure	Time frame
1)Hemodynamic Variables: oHeart Rate,Systolic blood pressure,Diastolic blood pressure, Mean Arterial Pressures 2) Duration of analgesia Timepoint: 5 min before Spinal Anesthesia (SA), 2 min, 4 min, 6 min, 8 min, 10 min,15 min, 20 min, 25 min, 30 min, 45 min, 60 min after SA.	—

Secondary

Measure	Time frame
Spinal Anesthesia onset Profile: o Sensory level of block o block onset time o Bromage score 2) Recovery Profile: Time for two segment regression, L1 regression time, Time to S2 Regression, Motor paralysis at L1 regression and S2 regression,Timepoint: 5 min before Spinal Anesthesia (SA), 2 min, 4 min, 6 min, 8 min, 10 min,15 min, 20 min, 25 min, 30 min, 45 min, 60 min after SA.	—

Countries

India

Contacts

Public ContactKopparapu Sai Charan Sateeesh

Military Hospital,Secunderabad

drcherry0903@gmail.com8895229535

Outcome results

None listed

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