| CTRI Number |
CTRI/2025/03/082969 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Quality of recovery after Hip replacement surgery |
|
Scientific Title of Study
|
Quality of Recovery after Total Hip Replacement: A Randomised Double-Blinded Study Comparing Intrathecal Morphine and Ultrasound Guided Sacral Erector Spinae Block |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananya Mishra |
| Designation |
PG Resident |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
C/O- Dr Alok Kumar Sahoo
Dept of Anesthesiology & Critical Care
Fifth Floor Room No-8
Hospital Building.
AIIMS Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
7987349801 |
| Fax |
|
| Email |
mishraananya94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room No 8. 5th Floor Hospital Building
Khordha ORISSA 751019 India |
| Phone |
9438884160 |
| Fax |
|
| Email |
alokks108@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Alok Kumar Sahoo |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no8, 5th floor Hospital Building.
AIIMS, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884160 |
| Fax |
|
| Email |
alokks108@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Bhubaneswar, Dist-Khordha
Odisha, 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS, Sijua. Bhubaneswar, Khordha, Odisha, 751019 |
| 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 Ananya Mishra |
AIIMS |
Room No 8, Hospital Building, AIIMS, Bhubaneswar Khordha ORISSA |
7987349801
mishraananya94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS, Bhubaneswar, Level 3 Academic Block |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M160||Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: M16||Osteoarthritis of hip, (3) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Morphine(ITM Groups) |
100 mcg of Morphine will be mixed with 0.5% hyperbaric Bupivacaine 15 mg and a sham block will be given postoperatively |
| Intervention |
Ultrasound guided Sacral erector spinae plane block(ESPB Group) |
Postoperative USG guided sacral erector spinae plane block (ESPB) with30 mL of 0.25% of Bupivacaine in a patient operated under SA with bupivacaine 0.5% 15 mg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-80 years, ASA grade I, III, scheduled for elective primary total hip replacement surgery
|
|
| ExclusionCriteria |
| Details |
Patients with bleeding disorders
Injection site infection
Vertebral column anomaly
Neurological disorders
Refusal to consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery using the QoR-15 score . |
24 hours after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the post-operative pain measured with NRS (0-10) score |
at 2, 4, 12, and 24 hours after surgery. |
| To compare time (in min) to first rescue analgesia |
|
| Opioid requirement during the postoperative period |
24hr of surgery |
| Incidence of PONV, Pruritus, Urinary retention |
24 hr. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip fractures and avascular necrosis are the leading causes of hip joint
replacement in India, and the incidence is multiplying. Pain following THR
surgery is a significant concern, and it could be as high as 81%, as reported
by previous studies, with the mean persistent
post-surgical pain rate being around 16.5%. [1] Adequate analgesia with minimal
side effects allows for early postoperative mobility, optimal
functional recovery, and decreased postoperative morbidity [2]. Despite being a frequently performed surgical procedure, there is
high variability in the peri-operative anaesthetic and analgesic management for
total hip arthroplasty [3, 4]. There is strong
evidence supporting the effectiveness of intrathecal morphine for pain
relief after total hip arthroplasty, with no significant increase in the risk
of respiratory depression with dose between 50 mcg to 100 mcg even in elderly and patients with risk of apnea.[5] The incidence of postoperative nausea and vomiting (PONV) after intrathecal
morphine is dose dependent and dose less than equal to 100 µg provide sufficient analgesia without
increasing the risk of PONV. [5,6] PROSPECT guidelines for THR surgery
recommend consideration of 100 mcg of intrathecal morphine administration if
the procedure is being done in spinal anaesthesia.
[4]
The ESPB is a regional block that
targets both the dorsal and ventral roots of the spinal nerve, offering
analgesia for both somatic and visceral pain. This technique facilitates the extensive distribution of local
anaesthetics in a craniocaudal direction, effectively blocking multiple
dermatomes. [4] Recently, some case studies suggested that the sacral erector
spinae plane block (ESPB) also called as sacral multifidus block, was found to be an effective technique for providing
postoperative pain relief in patients undergoing femoral fracture surgery via a
posterolateral approach. [4] But this technique has not been
extensively studied for adult patients undergoing hip surgeries. There is
paucity of literature comparing sacral ESPB and ITM which has quality of
recovery (QoR15) as the primary outcome in THR surgery. Hence, we plan to compare
effect of sacral ESP block with intrathecal morphine in the quality of recovery
at 24hr after THR surgery.
|