CTRI/2024/01/060995
Active, not recruiting
Phase 3 4
A prospective randomised trial comparing postoperative pain relief between bilateral external oblique intercostal plane block and intravenous morphine in patients after upper abdominal surgeries
Nivedhyaa1 site in 1 country66 target enrollmentStarted: January 8, 2024Last updated:
Overview
- Phase
- Phase 3 4
- Status
- Active, not recruiting
- Sponsor
- Nivedhyaa
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Mean requirement of intravenous morphine in either groups as rescue analgesic
Overview
Brief Summary
This is a study for comparing postoperative pain relief between the external oblique intercostal plane block and intravenous morphine in upper abdominal surgeries when the patient has a pain score greater than 3.Patients are generally treated with epidural drugs for pain relief.Inspite of that if they have pain in the postoperative period they will be randomised and given either the block or intravenous morphine.Then the difference in pain scores before and after the block will be seen
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients who report moderate to severe upper abdominal pain, defined as a pain score on the numerical rating scale (NRS) of 0-10 as 4 or above for the first three days (POD 0,1,2 and 3) at rest or due to movement or spirometry, in the postoperative period will be included both elective and emergency surgeries 2.Patient who have given informed consent for the procedure.
- •3.Age of 18 and above 4, Surgeries with upper abdominal incisions including gastric surgeries, splenectomy, cholecystectomy, hepatectomy will be included for the study.
Exclusion Criteria
- •1.renal diseases with elevated serum creatinine level more than 1.5mg% 2.Local skin site infection at the site of epidural or at the site of the EOIPB as identified before surgery 3.Patient refusal to give consent for epidural or blocks 4.History of known allergies to local anaesthetics or morphine .Suspected bowel obstruction : in this case we cannot use opioids 6.Patient would get discharged in less than 24 hours.
- •7.Drowsy patient who cannot tell about the pain score appropriately 8.Patients in whom epidural catheter will not be placed (as known preoperatively due to low platelet count or altered coagulation profile) 9.Patients who have been treated with tablet morphine in the preoperative period for pain.
Outcomes
Primary Outcomes
Mean requirement of intravenous morphine in either groups as rescue analgesic
Time Frame: Mean requirement of intravenous morphine in either groups as rescue analgesic upto 24 hours
Secondary Outcomes
- Pain Intensity Difference(Side Effects)
Investigators
Nivedhyaa S
Cancer Institute (WIA),Adyar
Study Sites (1)
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