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

Phase 2/3

Not yet recruiting

• Conditions: Encounter for cesarean delivery without indication,

• Registration Number: CTRI/2020/08/027280
• Lead Sponsor: SGRDIMSAR

Brief Summary

Spinal opioids potentiate the effect oflocal anesthetic agent providing longer lasting postoperative analgesia. Wecompared injection nalbuphine and butorphanol as an adjuvant to bupivacainewith respect to onset, duration of sensory and motor block, duration ofanalgesia, fetal outcome using APGAR and cord blood ph. Totalof 90 patients divided randomly into three groups Group A(n=30)0.5% bupivacaine10 mg(2ml)with 400μg nalbuphine diluted upto 2.2ml, Group B(n=30)0.5%bupivacaine 10 mg(2ml) with 25 μg butorphanol diluted upto 2.2ml, Group C(n=30)0.5%bupivacaine 10 mg(2ml) with normal saline diluted upto 2.2ml. Total volumeinjected will be 2.2 ml.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-19
• Study Start: 2020-08-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate duration of analgesia using 0.5% bupivacaine without or with nalbuphine hydrochloride (400 μg) vs butorphanol (25 μg) as adjuvant for subarachnoid block being given for LSCS.	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 Outcome Measures

Name	Time	Method
1.Onset, duration motor blockade and the hemodynamic changes in perioperative period.	2.Fetal outcome using APGAR, cord blood ph.

Trial Locations

Locations (1)

SGRDIMSAR; 🇮🇳 Amritsar, PUNJAB, India

SGRDIMSAR

🇮🇳Amritsar, PUNJAB, India

Dr Ruchi Gupta

Principal investigator

9814320805

drruchisgrd@gmail.com