To Compare post op pain relief in fracture femur surgeries with 3 in 1 block using levobupivacaine alone and tramadol and butorphanol as adjuvants

Phase 2/3

Not yet recruiting

Brief Summary: Postoperativepain is often undertreated. Safe and effective pain management should be theprimary goal to improve patient rehabilitation and satisfaction. Post operativepain relief can be achieved by a variety of techniques including parentalNSAIDS (non-steroidal anti-inflammatory drugs), opioids, epidural analgesia,patient controlled analgesia and peripheral nerve blocks. Three in one femoralnerve block is relatively simple to perform, effective, low risk technique witha high success rate.

The 90 patients ASA grade I-II in age group 18-80years undergoing fracture femur surgery at SGRD Amritsar will be studied withthe aim of evaluating the effectiveness of addition of tramadol or butorphanolas adjuvants to levobupivacaine vs levobupivacaine and saline through 3 in 1femoral nerve block randomly divided into 3 groups with 30 patients eachreceiving preemptive three in one nerve block either using 0.25%Levobupivacaine alone (Group I) or tramadol 1mg/kg (Group II) or butorphanol 0.06mg/kg as adjuvant to 0.25% levobupivacaine (Group III). To every patientspinal anaesthesia using 0.5% heavy bupivacaine will be given. Ease ofpositioning, pain relief, and duration of post operative analgesia in all thethree groups will be compared. In addition, post operative requirement ofintravenous diclofenac 75 mg will be evaluated.

Recruitment & Eligibility

Inclusion Criteria

ASA Grade I-II undergoing femur fracture surgeries.

Exclusion Criteria

1.A known history of allergy, sensitivity or any kind of reaction to the drugs used in the study.
2.Contraindication to neuraxial blockade (less platelet count, significant neurological disease, diagnosed increased intracranial pressure, epidural lipomatosis, tumors fracture spine, caudaequina syndrome) 3.Bleeding disorders.
4.Large inguinal lymph nodes or tumor 5.Psychiatric patients/ Unco-operative patients.

Primary Outcome Measures

Name	Time	Method
To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using	From the start of the Femoral nerve block to the 24 hrs after surgery
â€¢0. 25% levobupivacaine and normal saline	From the start of the Femoral nerve block to the 24 hrs after surgery
â€¢0. 25% levobupivacaineand tramadol	From the start of the Femoral nerve block to the 24 hrs after surgery
â€¢ 0. 25% levobupivacaine and butorphanol	From the start of the Femoral nerve block to the 24 hrs after surgery

Secondary Outcome Measures

Name	Time	Method
To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using in terms of ease of positioning, duration of postop analgesia, requirement of rescue analgesia and adverse effects.	From the start of the Femoral nerve block to the 24 hrs after surgery

Locations (1): Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar
🇮🇳
Amritsar, PUNJAB, India
Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar
🇮🇳Amritsar, PUNJAB, India
Dr Ruchi Gupta
Principal investigator
9814320805
drruchisgrd@gmail.com