Does pregabalin decrease pain and anesthetic medication requirement in treatment of subarchanoid haemorrhage?

Completed

• Conditions: Aneurysmal subarachnoid haemorrhage

• Registration Number: CTRI/2016/10/007363
• Lead Sponsor: Sree Chitra Tirunal Institute of Medical Sciences and Technology

Brief Summary

Acute aneurysmal subarachnoid haemorrhage (aSAH) is a catastrophic event wherein patientspresent with excruciating headache, often described as “thunderclap headache†which probably neuropathic in origin. It is of paramount importance to control the pain in this subset of patients. Pain results inactivation of the sympathetic system resulting in an increase in the blood pressure and an increase in the level of stress hormones as well. Pregabalin(β-isobutyl-GABA), alipophilic structural analogue of γ-Amino-butyric acid and a potent gabapentinoid, hasantiepileptic, antiemetic and anxiolytic properties that might make it particularly attractive inmanaging pain due to sub-arachnoid haemorrhage.

The primary objective of this trial is to evaluate the hypothesis that peri-operative oral pregabalindecreases intraoperative anaesthetic and opioid requirement and peri operative headache inpatients with aneurysmal sub arachnoid haemorrhage in patients on standard of care analgesics(Tab Paracetamol 650mg eighth hourly).

The secondary objectives will be to assess

1. a)  Pre-operative Visual Analogue Score (VAS)

2. b)  Time to recovery from anaesthesia as observed by the patient’s ability to follow commands from the time the anaesthetic was discontinued

3. c)  Post operative VAS scores at 6 hours, 12 hours and 24 hours after surgery

4. d)  Use of rescues analgesics in the peri-operative period

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-14
• Study Completion: 2017-07-17
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Sub arachnoid haemorrhage as evidenced by CT, CT Angiography, DSA, MR Angiogram Symptomatic headache Able to swallow oral medication Able to verbalize pain score Time period between the time of aneurysm bleed to enrolment into the study should be less than three days.

Exclusion Criteria

• Being on pregabalin or gabapentin derivatives in the past two weeks Pregnancy / Lactation Renal failure (Se Creat >1.4mg%) Patients with chronic pain syndromes on chronic pain medication SAH grading.
• WFNS grade 3, 4 & 5 ASA (American Society of Anaesthesiology) 3,4 and 5 Known allergy to Tab Paracetamol or Tab Pregabalin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fentanyl in mcg/kg (above the baseline infusion)	at the end of surgery

Secondary Outcome Measures

Name	Time	Method
Visual analogue score	pre-induction for surgery
Visual analogue score for pain	6, 12 and 24 hours post operation

Trial Locations

Locations (1)

Sree Chitra Tirunal Institute of Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Chitra Tirunal Institute of Medical Sciences and Technology

🇮🇳Thiruvananthapuram, KERALA, India

Dr Karen Ruby Lionel

Principal investigator

07560961638

karen@sctimst.ac.in