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CTRI Number  CTRI/2017/02/007905 [Registered on: 17/02/2017] Trial Registered Prospectively
Last Modified On: 16/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of local anaesthetic for Quadratus Lumborum muscle Block in patients undergoing surgical removal of uterus and its effect on requirement of post operative pain relief medications 
Scientific Title of Study   Comparison of ultrasound guided Quadratus Lumborum Block with intravenous patient controlled analgesia in patients undergoing Total Abdominal Hysterectomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanvi Khera 
Designation  Post Graduate Junior resident  
Affiliation  Government Medical College and Hospital Chandigarh  
Address  Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  7696227898  
Fax    
Email  tanvi.khera92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Palta 
Designation  Professor  
Affiliation  Government Medical College and Hospital Chandigarh  
Address  Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121523  
Fax    
Email  sanjeev_palta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tanvi Khera 
Designation  Post Graduate Junior resident  
Affiliation  Government Medical College and Hospital Chandigarh  
Address  Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  7696227898  
Fax    
Email  tanvi.khera92@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Chandigarh 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanvi Khera  Government Medical College and Hospital  Department of Anaesthesia and Intensive care , Government Medical College and Hospital sector 32 Chandigarh
Chandigarh
CHANDIGARH 
7696227898

tanvi.khera92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  patients undergoing Total Abdominal Hysterectomy, (1) ICD-10 Condition: N949||Unspecified condition associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C- Patients will receive only intravenous patient controlled analgesia.  patients will receive only intravenous patient controlled analgesia. 
Intervention  Group Q- patients will receive bilateral quadratus lumborum Block with 0.2% Ropivacaine along with intravenous patient controlled analgesia.   patients will receive ultrasound guided bilateral quadratus lumborum Block with 0.2% Ropivacaine along with intravenous patient controlled analgesia.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Females suffering from pathology requiring total abdominal hysterectomy
2. American Society of Anesthesiologists physical status I-II 
 
ExclusionCriteria 
Details  1. History of relevant drug allergy
2. History of psychiatric illness, substance abuse
3. Severe cardiovascular, respiratory, liver diseases metabolic or neurological disease
4. Chronic treatment with analgesics
5.Coagulopathy
6.Infection at planned injection site
7.Psychological inability of the patient to understand visual analogue scale
8.History of intake of drugs such as imipramine, theophylline, fluvoxamine and antiarrhythmic agents
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyze the intensity of post-operative pain relief in both groups by visual analogue scale  30mins, 1hr, 4hrs, 8hrs, 12hrs, 24hrs, 36hrs and 48 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze total cumulative morphine consumption in both the groups over 48 hours  30mins, 1hr, 4hrs, 8hrs, 12hrs, 24hrs, 36hrs and 48 hrs. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/03/2017 
Date of Study Completion (India) 04/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Abdominal hysterectomy is one of the most frequently performed gynecological surgery these days. Post procedural pain is the main concern in patients undergoing any operative intervention. In addition to the somatic and visceral components in the early post-operative period, inadequate pain relief has a propensity to progress to chronic pain syndromes that may have debilitating impact on the quality of life The pfannenstiel incision which is the most commonly used incision in cesarean section and total abdominal hysterectomy(TAH) has also been associated with development of chronic pain syndromes if the acute pain of surgery is not managed adequately.

Many analgesic practices have been carried out to alleviate the pain associated with abdominal hysterectomy such as use of oral analgesics which may be opioid or non-opioid, intravenous patient control analgesia system, local infiltration at the surgical site and neuraxial analgesia via epidural or intrathecal route. There is rising concern with the use of opioids as the sole analgesic modality as it can lead to significant amount of post-operative nausea vomiting (PONV), pruritus, drowsiness, respiratory depression and other systemic side effects. Use of local infiltration or non-opioid preparations as unimodal analgesic are usually inadequate in providing pain relief. Neuraxial analgesia via epidural or intrathecal route for post-operative pain control may not be a convenient route as they need catheter based continuous infusion or repeated bolus to provide adequate effect. Other modes of analgesia available for patient undergoing abdominal hysterectomy are the ultrasound guided nerve blocks (ilio-inguinal nerve block) and inter-fascial plane blocks (Transversus abdominus muscle plane block).Since the advent of ultrasound in anaesthesia various modalities are being defined and refined to provide pain relief considering the safety profile associated with techniques done with the aid of ultrasound. With increasing application of ultrasound in anaesthesia practice, interest in interfacial plane blocks has also increased owing to improved visualization of the anatomical structures.A recent development in the field of post-operative analgesia is the ultrasound guided Quadratus lumborum block (QLB) which has been shown to provide effective analgesia in patients undergoing lower abdominal surgeries. Originally described by Blanco in 2007, QLB was further modified by Borglum, who deposited the drug in the inter-fascial plane between quadratus lumborum muscle and psoas major in a trans-muscular approach.This leads to extensive thoracolumbar anaesthesia (T6-L1). He also postulated the spread of local anaesthesia to thoracic paravertebral spread (TPVS), as both psoas and quadratus lumborum muscles have their embryonic origin and insertion within the thoracic cage.

Both cesarean section and TAH utilize the same surgical field and abdominal incision (pfannenstiel incision). The nerves that innervate the supra pubic and lower abdominal portion may get damaged or trapped leading to neuroma formation especially when the incision is extended beyond the lateral edges of the rectus sheath, thus leading to neuropathic pain in the post-operative period.This may lead to development of chronic pain.

Hence, the present study aims at comparing the effectiveness of ultrasound guided quadratus lumborum block (QLB) with intravenous Patient controlled analgesia (IV-PCA) for adequate post-operative analgesia in patients scheduled to undergo total abdominal hysterectomy (TAH).

 
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