| CTRI Number |
CTRI/2020/03/024315 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
To study pain relief after nerve block given post caesarean delivery .
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Scientific Title of Study
|
To study the efficacy of ultrasound guided Quadratus Lumborum block for post operative analgesia after lower segment caesarean section:a randomised prospective controlled study |
| 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 |
Dr Pragya Shukla |
| Designation |
JR |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology,
sgpgims
Lucknow Department of Anaesthesiology,
sgpgims
Lucknow Lucknow UTTAR PRADESH 226014 India |
| Phone |
7599296498 |
| Fax |
|
| Email |
pragyashuklakgmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandeep Sahu |
| Designation |
Additional professor |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology,
sgpgims
Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904598 |
| Fax |
|
| Email |
drsandeepsahu09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandeep Sahu |
| Designation |
Additional professor |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology,
sgpgims
Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904598 |
| Fax |
|
| Email |
drsandeepsahu9@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr Sandeep Sahu |
| Address |
Additional Professor,
Department of Anaesthesiology,
sgpgims,
lucknow |
| Type of Sponsor |
Other [self] |
|
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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 |
| Dr Sandeep Sahu |
SGPGI ,LUCKNOW |
department of maternal and reproductive health,
second floor,
PMSSY BLOCK,
SGPGIMS,LUCKNOW
226014 Lucknow UTTAR PRADESH |
8004904598
drsandeepsahu09@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,sgpgi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumboum Block Group |
Quadratus Lumborum block will be given in pregnant females after their lower segmant caesarean section. |
| Comparator Agent |
Wound Infiltration Group |
Lower Segmant caesarean section wound will be infiltrated by same drug (as used in nerve block ) in patients after lower segment caesarean section surgery |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Adult female patients, ASA physical status I or II, with normal singleton pregnancy with a gestation of atleast 37 weeks who are scheduled for lower segment caesarean section under spinal anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal to partipate, coagulation disorders, signs of local or systemic infection, , patients with acute or chronic renal disease, spinal deformities, ASA grade 3 or 4 ,patients who used anticoagulants or were unable to comprehend or use the verbal rating pain scoring system or PCA pump . |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of USG guided Quadratus lumborum block (USG-QL) in reducing pain (static and dynamic) after LSCS |
At 0 (zero) hours,4 hours,8 hours,12 hours,16 hours,20 hours and finally 24 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of analgesia in both groups,
2.Pain- by NRS score
3.Total analgesic consumption : measure 24 hr fentanyl demands and doses delivered by patient controlled analgesia(PCA)
4.Rescue analgesia : Injection Tramadol ( need, freq, quantity)
5.Satisfaction score: of patient
6.Complications : Incidence of Post operative nausea and vomiting ,level of sedation
7.To study the side effects and complications related to ultrasound guided quadratus lumborum block if any.
|
At 0 (zero) hours,4 hours,8 hours,12 hours,16 hours,20 hours and finally 24 hours |
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Target Sample Size
Modification(s)
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "67"
Final Enrollment numbers achieved (India)="67" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
1. Kerai S, Saxena KN. Quadratus lumborum block for post-caesarean analgesia. Indian J Anaesth. 2017;61(4):364. doi:10.4103/ija.IJA_220_17
2. Nair A. Bilateral quadratus lumborum block for post-caesarean analgesia. Indian J Anaesth. 2017;61(4):362–363. doi:10.4103/ija.IJA_204_17
3. Sebbag I, Qasem F, Dhir S. Bloqueio do quadrado lombar guiado por ultrassom para analgesia pós cesariana: série de casos [Ultrasound guided quadratus lumborum block for analgesia after cesarean delivery: case series]. Rev Bras Anestesiol. 2017;67(4):418–421. doi:10.1016/j.bjan.2017.03.002
4. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015;32(11):812–818. doi:10.1097/EJA.0000000000000299
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
As pain is ranked highest among undesirable clinical outcomes associated with caesarean section and it interferes with both mother and new born care ,so we are doing this study to see the role of levobupivacaine (which is used world wide for nerve blockade ) and efficacy in reducing post operative analgesia after caesarean section and we will also compare it with wound infiltration of same drug.Although IT and epidural morphine remain the most popular form of acute pain control for Caesarean pain, more than 70% of patients require additional analgesia. Furthermore, the sideeffect profile should not be underestimated; as many as 87% of patients experience pruritus and up to 70% experience urinary retention. Nausea and vomiting have also been well-established side effects, leading to significant discomfort for a new mother trying to provide acute infant care. Although nonsteroidal anti-inflammatory drugs and acetaminophen are helpful opioid-sparing multimodal adjuncts, the role of regional anaesthesia in improving Caesarean pain requires additional exploration. An IV PCA pump with demand dosing of opioids (fentanyl) provides effective pain relief after LSCS surgeries. However there are very limited studies on the assessment of analgesic efficacy and side effects of Quadratus lumborum block after caesarean section , as it confer major advantage over IVPCA alone because the regimen including background infusion increases total drug dosage and side effects without significantly improving analgesic efficacy. So, we designed a prospective, randomized study to evaluate the efficacy and side effects of quadratus lumborum block with levoboupivacaine in patients undergoing LSCS and taking patients with wound infiltration with same drug and as control group .We wish to compare between these two groups and conclude the best amongst the two. Following approval by the Institutional Ethics Committee, study would be completed in the period of 2 years. After taking written and informed consent from the patient, this study would be conducted in adult pregnant females with normal singleton pregnancy with a gestation of atleast 37 weeks undergoing lscs under spinal anaesthesia. Spinal anaesthesia will be administered with 27 G pencil tip needle, 2.0 ml heavy bupivacaine Patients will be immediately placed in supine position and spinal anaesthesia will be considered successful when a bilateral block to T6 , assessed by loss of cold(spirit swab) and touch (blunt pain ) discrimination will be established While in supine position ,patients will receive bilateral QLB at the end of surgrey .QLB will be performed under USG guidance using broad band (5-8MHz) convex probe .After cleaning abdomen with povidone iodine ,probe will be placed at ASIS and moved cranially until three abdominal wall muscles are clearly identified The needle will be inserted in plane from medial(anterior)to lateral (posterior).The optimal point of injection will be determined using hydrodissection . Assessment of pain will be done by a 11 point numerical rating scale (NRS); 0= no pain, 10 = worst imaginable pain. Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 30 each with the help of a computer generated table of random numbers; each group will receive post operative iv pca infusion with a solution containing 10 μg ml-1 fentanyl at a rate required by the patient. QL BLOCK Group: USG guided QL block with 0.25 % 20 -30ml levobupivacaine and IV Paracetamol 8 hourly, up to 24 hours postoperatively. CONTROL Group: wound infiltration with 0.25 % 20-30 ml levobupivacine and IV Paracetamol , 8 hourly up to 24 hours postoperatively. |