Comparison of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in spinal anaesthesia

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/03/082125

Lead Sponsor: Department of Anaesthesiology School of Medical Sciences and Research, Sharda University

Brief Summary: Neuraxial anesthesia is commonly performed for all surgical procedures carried on lower abdomen, pelvis and lower limbs to provide adequate surgical anesthesia and analgesia. It has a definite advantage over general anesthesia by blocking nociceptive impulses from the operative site, reduced blood loss and decreased incidence of deep vein thrombosis. Levobupivacaine has become popular for central neuraxial blocks in this century. The main advantage includes ease of technique and reliability. Levobupivacaine a pure s-enantiomers of bupivacaine are safer alternative for regional anaesthesia than its counterpart with lower toxicity profile. Opioids are added to local anesthetic drugs intrathecally to provide synergistic effect and to improve the quality of intraoperative and postoperative analgesia. These agents when combined together result in a reduction in the dose of both classes of drugs, decreasing the likelihood of side effects related to each.

Extensive search of literature reveals that though the studies have been conducted with our additives with the drug bupivacaine, but a specific study comparing the additive effect of both the drugs with the recently introduced drug Levobupivacaine and a suitable dose required intrathecally has not been done extensively. Therefore, the present study is designed to compare the effect of intrathecal butorphanol and nalbuphine as an adjuvant to levobupivacaine in subarachnoid block.

The specific outcome measures to define the performance of our study will primarily include comparing the effect of both the adjuvant drugs administered on the duration of motor and sensory blockade.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

Patient scheduled for surgery under subarachnoid block 2.Age 18-60 years 3.
Both genders 4.
ASA grade I and II.

Exclusion Criteria

1.ASA grade III and IV 2.Patient refusal to participate in study 3.Morbid obesity 4.
Patient with history of adverse response to study drugs 5.
Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease.
Pregnant females 7 Coagulopathy or bleeding diathesis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time of onset and duration of sensory blockade assessed by pinprick and Visual Analog Score (VAS).	Post operative period
2. Time of onset and duration of motor blockade assessed by modified Bromage scale.	Post operative period
To compare the effect of intrathecal nalbuphine versus butorphanol as an adjuvant to 0.5% Levobupivacaine in subarachnoid block in respect to:	Post operative period

Secondary Outcome Measures

Name	Time	Method
1. Changes in vitals parameters-	Heart rate (HR), Noninvasive Blood Pressure (NIBP) & Oxygen Saturation (SPO2).

Trial Locations

Locations (1): SMS&R, Sharda University
🇮🇳
Nagar, UTTAR PRADESH, India
SMS&R, Sharda University
🇮🇳Nagar, UTTAR PRADESH, India
Manish Kumar Agarwal
Principal investigator
9838706199
dr.manishagarwal09@gmail.com