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
|
|
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
|
|
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). |