Comparing the postsurgical pain relieving effects of three groups of drugs in patient of open inguinal hernia repair posted under regional anaesthesia.

Recruiting

Conditions: ASA GRADE 1 ,ASA GRADE 2

Registration Number: CTRI/2018/04/013293

Lead Sponsor: Bhagat Phoot Singh Government Medical College For Women KhanpurKalan SonipatHaryana

Brief Summary: PROJECT SUMMARY: Prevention and treatment of postoperative pain continues to be a major concern in postoperative care and plays an important role in the early mobilization and well being of the surgical patient.Postoperative pain due to tissue injury and surgical trauma is associated with neuroendocrine stress responses, catecholamine,inflammatory mediator release, and central sensitization,which is considered to be one of the mechanisms responsible for the persistence of postoperative pain.Preventing central sensitization with multimodal analgesicinterventions could reduce the intensity or even eliminate acutepostoperative pain hyperalgesia and chronic pain after surgery.Role of pregabalinhas been established in literature for postoperative pain other than neuropathic painwith good results.[3,4] On the other hand Dexamethasone is known to have some analgesic,antiemetic properties but its efficacy as an adjuvant analgesic for postoperative pain in cases under spinal anaesthesia is not studied extensively. Recently few studies have shown the role of Vitamin B complex in Acute pain although there is limited literature supporting its adjuvant analgesic role for postoperative pain.However there is paucity of studies in comparison with pregabalin alone with dexamethasone and pregabalin with vitamin B complex for postoperative pain. This study is designed to compare their efficacy with respect to increase in duration of analgesia, reduction in total post- operative requirements of analgesics and study side effects and complications in Three groups.One twentysix patients of either sex in ASA grade I and II were randomly allocated to one of the three groups of fortytwo each. The patients in Group I will be given single dose of oral capsulePregabalin 300mg with IV Placebo in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of Open Inguinal hernia repair.Group II will be administered oral capsule Pregabalin 300mg with IV Inj Dexamethasone 8 mg in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair.Group III will be administered oral capsule Pregabalin 300 mg with Inj VitaminB complex(Inj Thiamine 1gm, pyridoxine hydrocloride 1gm,Cyanocobalamine 100mcg,Dexpanthenol 15mg) in 100ml NS( over 15 minutes, close watch for hypersensitivity reaction for 5 minutes,if present stop infusion and noted )one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair. The patients will be observed periopeatively for variations in haemodyanamic parameters, sedation scores and incidence of adverse effects among the groups.Postoperatively pain was assessed by Visual Analogue Scale immediate postoperatively and upto 24 hours thereafter. Time since spinal anaesthesia to first dose of analgesic and total dose of analgesic in first 24 hours will be recorded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 126

Inclusion Criteria

Patient consented for the study Patient of Age Group : 20-60 years Patients with American society of anaesthesiologists I or II Patient of any gender posted for inguinal hernia repair.

Exclusion Criteria

Patients with refusal to enter the study Patients with American society of anaesthesiologists III, IV or V Pregnant females Patient with History of Renal disease Patient with History of seizure or other neurological disorders Patient currently taking Gabapentin or Pregabalin for other medical purpose Patient with known history of allergic reaction to pregabalin from previous use Patients with known history of allergic reaction to vitamin b complex Patients with comorbid diseases like diabetes, hypertension, neurological, psychiatric or neurovascular disorder Patients having absolute contraindication for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome will be to compare efficacy of drug combinations in prevention of postoperative pain .	upto 24 hours

Secondary Outcome Measures

Name	Time	Method
Secodary outcome is to compare haemodynamic staus and incidence of side effects.	upto 24 hours

Trial Locations

Locations (1): Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
🇮🇳
Sonipat, HARYANA, India
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan,Sonipat,Haryana
🇮🇳Sonipat, HARYANA, India
Deepak Gupta
Principal investigator
8059779684
deepakgupta_lko@yahoo.com