Home » Trials » SLCTR/2016/011


A double blinded randomized control trial on the effects of standard local infiltration vs laparoscopic guided transverse abdominis plane block for pain relief in laparoscopic cholecystectomy -

SLCTR Registration Number

SLCTR/2016/011


Date of Registration

22 Apr 2016

The date of last modification

Nov 20, 2017



Application Summary


Scientific Title of Trial

A double blinded randomized control trial on the effects of standard local infiltration vs laparoscopic guided transverse abdominis plane block for pain relief in laparoscopic cholecystectomy


Public Title of Trial

A study comparing two different methods of pain relief following cholecystectomy


Disease of Health Condition(s) Studied

Post cholecystectomy pain relief


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

P/163/10/2015 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)


Trial Details


What is the research question being addressed?

What is the efficacy of laparoscopic guided transverse abdominis plane block in comparison with conventional port site infiltration for postoperative pain relief following laparoscopic cholecystectomy?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Standard therapy


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

The study will be carried out in wards 19 and 20 of the North Colombo Teaching Hospital, Ragama, Sri Lanka.

Consenting patients meeting the inclusion/exclusion criteria will be allocated using random number tables into either the intervention or control arm immediately prior to surgery.

The intervention arm will receive unilateral sub costal transverse abdominis plane block with 40ml of 0.25% plain bupivacaine + local infiltration of 0.5% plain bupivacaine 5-10ml at each port sites. (The port sites will be epigastric, right iliac fossa, right hypochondrium and umbilical.)

The control arm will receive only local infiltration of 0.5% plain bupivacaine 5-10ml at each port sites. (The port sites will be epigastric, right iliac fossa, right hypochondrium and umbilical.)

The interventions will be carried out by an investigator and the patients then handed over to the surgeon who will be blind to the intervention status of the patient. All interventions will take place once the patient is under general anaesthesia, and thus blind to their intervention status.

Outcomes will be assessed by an independent investigator who will also be blinded to the intervention status.


Inclusion criteria

All patients undergoing elective laparoscopic cholecystectomy


Exclusion criteria

  1. Patients who undergo emergency laparoscopic cholecystectomy
  2. Conversion from laparoscopy to open cholecystectomy
  3. Patients with blood coagulation pathologies
  4. Known allergy to local anesthetic drugs
  5. Duration of surgery more than two hours
  6. Patients with intra operative or perioperative complications
  7. Pregnant women
  8. Body weight less than 30kg


Primary outcome(s)

Need for post-operative rescue analgesia with sub cutaneous morphine


Primary outcome(s) - Time of assessment(s)

At 36 hours post operatively


Secondary outcome

  1. Post operative pain (assessed by visual analog score)
  2. Duration of immobilization
  3. Occurrence of post operative vomiting
  4. Duration of hospital stay

Secondary outcome(s) - Time of assessment(s)

  1. Post operative pain (assessed by visual analog score)
  2. Duration of immobilization
  3. Occurrence of post operative vomiting
  4. Duration of hospital stay


Target number/sample size

90 (45 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-05-01


Anticipated end date

2016-11-01


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 14.10.2015 (Ref: P/163/10/2015)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Rohan Chaminda Siriwardana
Consultant hepatobiliary surgeon
Department of Surgery, Faculty of Medicine, Ragama
Tel: 0775544015
Mob: 0777250213

rohansiriwardana@yahoo.com

Contact Person for Public Queries

Dr. Rohan Chaminda Siriwardana
Consultant hepatobiliary surgeon
Department of Surgery, Faculty of Medicine, Ragama
Tel: 0775544015
Mob: 0777250213

rohansiriwardana@yahoo.com


Primary study sponsor/organization

Department of Surgery, Faculty of Medicine, University of Kelaniya

Thalagolla Rd, Ragama, Sri Lanka
Tel: +94112961000
Fax: +94112958337

Web: http://www.kln.ac.lk/medicine/depts/surgery/

Secondary study sponsor (If any)

None