A clinical trial to examine whether administering a low dose spinal anesthesia along with general anesthesia will give better pain relief in patients undergoing laparoscopic hernia repair.

Phase 3

• Conditions: Inguinal hernia, laparoscopic repair

• Registration Number: CTRI/2010/091/000249
• Lead Sponsor: S.Rajeshwari

Brief Summary

This is a randomized, prospective, placebo controlled, parallel group study comparing general anesthesia alone with general anesthesia and 'add on' low dose spinal anesthesia in patients undergoing laparoscopic hernia repair.The primary outcome measures will be intra operative and post operative fentanyl sparing effect of spinal anesthesia, and effect on quality of recovery.Secondary outcome measures will be intra operative hemodynamic stability and post operative nausea and vomiting.Patients will be followed for 24 hours post operatively.All patients will have access to a patient-controlled analgesia (PCA) device which they can activate to get bolus doses of IV fentanyl.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• (i) Adult males,Age 20 ?
• 65 years(ii) Unilateral or bilateral reducible inguinal herniae(iii) Scheduled for Total Extra Peritoneal (TEP) repair under geneal anesthesia.

Exclusion Criteria

(i) Uncontrolled systemic illness(ii) Neurological illness (Parkinsonism, h/o CVA) (iii) Any contraindications to spinal anaesthesia (local infection, coagulopathy, documented anatomical abnormality, allergy to local anaesthetic agents)(iv) Patients undergoing Trans Abdominal Pre Peritonal(TAPP)repair(v) Irreducible herniae(vi) Patients with other surgical procedures performed concurrently(vii) Patient refusal for the study.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Incidence of pain after laparoscopic hernia repair2)Intra- and post operative opioid sparing effect of low dose spinal anesthesia3)Quality of recovery -effect of low dose spinal anesthesia	Post operatively, 6 hourly, for 24 hours

Secondary Outcome Measures

Name	Time	Method
1) Intra operative hemodynamic stability2) Post operative nausea and vomiting3) Side effects related to sub arachnoid block	Intra operative and up to 24 hours post operatively

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

S.Rajeshwari

Principal investigator

09810079229

drsrajeshwari@gmail.com