to compare the quality of pain relief with two drugs given in spinal anaesthesia forlower segmemt cesarean section

A study to evaluate the duration of post operative analgesia using nalbuphine or butorphanol as adjuvant to intrathecal 0.5% bupivacaine compared to 0.5% bupivacaine alone in lower segmemt cesarean section

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027280

Enrollment

Registered

2020-08-20

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: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Intrathecal administration of study drugs: Intrathecal administration of study drugs nalbuphine or butorphanol as adjuvant to 0.5% bupivacaine compared to 0.5% bupivacaine alone in lowe

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who are willing to undergo the study. 2.Patients undergoing elective LSCS 3.Patients American Society of Anesthesiology (ASA) Grade II

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Patient with Cardiorespiratory problems 3. Patient with Coagulopathy 4. Patient with Neurological disease 5. Patient with Psychological disease 6. Patient with Endocrine disease and allergy to used drugs 7. Contraindication to drugs. 8. Complicated pregnancy.

Design outcomes

Primary

Measure	Time frame
To evaluate duration of analgesia using 0.5% bupivacaine without or with nalbuphine hydrochloride (400 Î¼g) vs butorphanol (25 Î¼g) as adjuvant for subarachnoid block being given for LSCS.Timepoint: From the time the sensory block reaches the maximum level to requirment of first top up at NRS more than or equal to 4.	—

Secondary

Measure	Time frame
1. Onset, duration motor blockade and the hemodynamic changes in perioperative period. 2. Fetal outcome using APGAR, cord blood ph. 3. Sedation score. 4. Effect of adjuvants on sedation. 5. Doses of rescue analgesia required in 24 hours. 6. Correlation of pain free period to breast feeding and early ambulation to duration of analgesia. 7. Complications related to procedures and side effect of drugs. Timepoint: from the onset of sensory and motor block till 24 hours postoperatively.	—

Measure

Time frame

1. Onset, duration motor blockade and the hemodynamic changes in perioperative period. 2. Fetal outcome using APGAR, cord blood ph. 3. Sedation score. 4. Effect of adjuvants on sedation. 5. Doses of rescue analgesia required in 24 hours. 6. Correlation of pain free period to breast feeding and early ambulation to duration of analgesia. 7. Complications related to procedures and side effect of drugs. Timepoint: from the onset of sensory and motor block till 24 hours postoperatively.

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Countries

India

Contacts

Public ContactDr Sukhvir kaur

SGRDIMSAR

gitzgitz@gmail.com9872981079

Outcome results

None listed

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