| CTRI Number |
CTRI/2018/02/011800 [Registered on: 09/02/2018] Trial Registered Prospectively |
| Last Modified On: |
06/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Comparison of the post operative analgesic effect of 2 ultrasound guided peripheral nerve blocks (quadratus lumborum block and transversus abdominis plane block) in patients undergoing elective caesarean section |
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Scientific Title of Study
|
Comparison of ultrasound guided quadratus lumborum block and transversus abdominis plane block for post operative analgesia in patients undergoing elective caesarean section |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Nijhawan |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, 160030
Chandigarh CHANDIGARH 160030 India |
| Phone |
9780939105 |
| Fax |
|
| Email |
prernanijhawan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr RIcha Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government College and Hospital, sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr RIcha Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government College and Hospital, sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector 32-B, Chandigarh |
|
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Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and , Sector 32-B, 160030 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prerna Nijhawan |
Government Medical College and Hospital, Chandigarh |
Gynaecology Operation Theatre Complex, level 3, A block, Government Medical College and Hospital, sector 32, Chandigarh Chandigarh CHANDIGARH |
9780939105
prernanijhawan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH, Chandigarh) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant females (normal singleton pregnancy with gestation of 37 weeks or more) scheduled to undergo elective cesarean section with American Society of Anesthesiologists physical status I-II.
, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Quadratus Lumborum Block |
Under ultrasound guidance, local anaesthetic will be injected into the plane between quadratus lumborum muscle and psoas major muscle.
The patient will be positioned in the lateral decubitus position with the hip slightly adducted and flexed towards the same side. After ensuring full aseptic precautions and draping the area, a high-frequency (5–10 MHz) ultrasound probe (Sonosite, Inc. Bothell, WA 98021 USA) will be positioned between the iliac crest and subcoastal margin in the mid-axillary line, to appreciate the anatomy of the three layers of abdominal muscles. The probe would then be moved dorsally to identify the quadratus lumborum muscle, psoas muscle and transverse process of the L4 vertebrae. The shamrock sign will be identified with the quadratus lumborum muscle attachment to the apex of transverse process of the L4 vertebrae laterally, psoas major muscle anteriorly and the erector spinae muscle posteriorly. The Sono Plex Stim cannula (21GX 100mm, Pajunk, Germany) will be advanced from anterior to posterior through the quadratus lumborum muscle and its fascia. After negative aspiration and confirming the position of the needle, 0.25% of Ropivacaine 20 ml amount will be injected into the plane between quadratus lumborum muscle and psoas major muscle. The same procedure will be repeated on the opposite side to achieve bilateral block. |
| Comparator Agent |
Ultrasound guided transversus Abdominis Plane Block |
With the patient in supine position and ensuring full aseptic precautions, a high-frequency (5–10 MHz) ultrasound probe (Sonosite, Inc. Bothell, WA 98021 USA) will be placed longitudinally on the anterolateral abdominal wall between the iliac crest and the subcostal margin first. The muscles (external oblique, internal oblique and transversus abdominis) will be identified. Subsequent to identification of the neurofascial plane between the internal oblique and transversus abdominis muscle, a Sono Plex Stim cannula (21GX 100mm, Pajunk, Germany) will be introduced anteriorly in the plane of the ultrasound beam. The needle will be directed to approach the transversus abdomins plane and on entering the fascial plane, 20ml of 0.25% ropivacaine will be injected after negative aspiration. The procedure will be repeated on the other side. |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Pregnant females (normal singleton pregnancy with gestation of 37 weeks or more) scheduled to undergo elective cesarean section.
2 American Society of Anesthesiologists physical status I-II
3 Age 20-40 years.
|
|
| 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
9 Patient’s refusal for the procedure
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To calculate and compare the post operative opioid consumption over 24 hours in parturients undergoing elective caesarean section receiving quadratus lumborum block or transversus abdominis plane block. |
Patients would be continuously monitored for haemodynamic variables and recordings noted at 30 minutes,
1 hour, 4 hours, 8 hours, 12 hours and 24 hours. Simultaneously pain will also be assessed at rest and movement using VAS score and nausea and vomiting using categorical scoring system. The outcome will be assessed at the end of 24 hours. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare the reduction in pain intensity up to 24 hours by the use of visual analogue scale, the time to first analgesic requirement, to measure haemodynamic variables over 24 hrs, to calculate and compare the total dose of anti-emetics, to note any side effects pertaining to the procedure/drugs used.
|
Patients would be continuously monitored for haemodynamic variables and recordings noted at 30 minutes,
1 hour, 4 hours, 8 hours, 12 hours and 24 hours. Simultaneously pain will also be assessed at rest and movement using VAS score and nausea and vomiting using categorical scoring system. The outcome will be assessed at the end of 24 hours. |
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "600"
Final Enrollment numbers achieved (India)="600" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2018 |
| Date of Study Completion (India) |
12/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/05/2019 |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Caesarean section is one of the most commonly performed surgeries in obstetrics, either as an elective or emergency procedure. With advancements in the anaesthesia management and improvement in the surgical techniques, the morbidity related to this procedure has reduced. However, post procedural pain remains one of the main concerns in patients undergoing any operative intervention.Surgical trauma leads to acute post operative pain that ends with tissue healing. In addition to the somatic and visceral components of pain in the early post-operative period, inadequate pain relief also has a propensity to progress to chronic pain syndromes that may have debilitating impact on the quality of life.1The Pfannenstiel incision which is most commonly employed in caesarean 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.Adequate analgesia helps in reducing the post operative stress response and morbidity, thereby improving the surgical outcome and facilitating rehabilitation. Females who have undergone caesarean section have even more compelling reasons to achieve optimal post operative analgesia compared to other surgical patients. Immobility due to inadequate pain relief may precipitate thromboembolic events in the parturients and can also hamper the mother-child bond. Effective pain control helps in early recovery, ambulation as well as breastfeeding and care of the newborn.Various analgesic modalities have been used to alleviate the pain associated with caesarean sections such as the 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. All of these modalities carry their own advantages and disadvantages. 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 and vomiting (PONV), pruritus, drowsiness, respiratory depression and other systemic side effects. Use of local infiltration or non-opioid preparations as the only analgesic modality 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 boluses to provide adequate effect. With increasing application of ultrasound in anaesthesia practice, interest in interfascial plane blocks has also increased. Ultrasound guided nerve blocks (ilio-inguinal nerve block) and inter-fascial plane blocks such as Transversus abdominis muscle plane block and Quadratus Lumborum Block have gained popularity as other modes of analgesia in postoperative cesarean section patients.Ultrasound guided nerve blocks have several advantages such as guidance of the needle under real time visualization, direct drug deposition as well as visualization of neural structures and related structures like blood vessels and tendons.The Transversus Abdominis Plane (TAP) block is a regional analgesic technique that blocks abdominal neural afferents by introducing local anesthetic into the neurofascial plane between the internal oblique and the transversus abdominis muscles thereby reducing the post operative pain in caesarean sections. A loss of resistance technique was used to locate the transversus abdominis plane. Hebbard et al described an ultrasound guided technique for the TAP block in 2007 which helped in overcoming the imprecision in the blind technique as accurate needle placement could be facilitated using ‘real-time’ imaging.Another interfascial plane block which has been shown to provide effective analgesia in patients undergoing caesarean sections is the ultrasound guided Quadratus Lumborum Block (QLB). 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.Both these blocks have been shown to relieve post caesarean section pain, it may thus be reasonable to study their efficacy and compare them.Therefore, the present study is aimed at comparing the effectiveness of Ultrasound guided Quadratus Lumborum Block with Transversus Abdominis Plane block for adequate post operative analgesia in patients scheduled to undergo elective caesarean section. |