Comparison of pain relief in the postoperative period with Continuous epidural infusion and Patient controlled epidural device for patients undergoing major abdominal oncologic surgeries
- Conditions
- Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (3) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (4) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum, (6) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified,
- Registration Number
- CTRI/2020/01/022973
- Lead Sponsor
- St Johns Medical College
- Brief Summary
Objective of the is to compare the postoperative painrelief provided by two different modalities-Patient Controlled EpiduralAnalgesia (PCEA) and Continuous Epidural Analgesia (CEA) in patients undergoingmajor abdominal oncologic surgeries.
Studies comparing PCEA with CEA have often beenretrospective in design. The non-randomised nature of these studies resulted inan uneven distribution between the groups and possible bias- the effect of thePCEA may be due to the psychological factor of ‘self-control’ resulting in lesscomplaints, nurses may call pain service earlier in case of CEA, or delaybecause of the hassle involved in a top up dose. Hence validation through aprospective randomised controlled trial is required.
Many hospitals and anaesthesiologists continue usingCEA for reasons of simplicity, scarcity of PCA pumps and intricacy of handlingthese pumps. In our institution, CEA is the standard of care. Supervision andmonitoring of CEA given the logistics of a large hospital and teaching centrewith regards to response time, time to contact a physician to do a top up andassessment of side effects and dosage of drug consumed is difficult. PCEA ifestablished as a standard of care, can reduce the requirement for top ups,incidence of side effects and overall dose of local anaesthetic and/or opioid.
Identification of an effective postoperativeanalgesic modality in patients undergoing major abdominal oncologic surgeriescan in turn be useful in prescribing pain relief in patients undergoinggynaecologic, genitourinary, orthopaedic and thoracic surgeries.
Identification of a safe, practical and effectivepain relief method can help in early recovery after surgery and anaesthesia,prevent pharmacological side effects, lead to early ambulation of the patientand fulfilment of discharge criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 56
Patients above age of 18 years to 59 years belonging to ASA I, II, III undergoing major abdominal oncologic surgery in St. John’s Medical College Hospital during the study period.
- Patients who have a clinical or laboratory contraindication to the placement of an epidural catheter like bleeding diathesis, severe hypovolemia, elevated intracranial pressure (particularly with an intracranial mass), severe aortic stenosis, severe mitral stenosis and infection at the site of injection.
- Inability to use the PCEA device Patient posted for Gastrectomy.
- Patients who have a known allergy to the local anaesthetic or opioid used Patient refusal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of PCEA and CEA in post op pain management in terms of To compare the efficacy of PCEA and CEA in post op pain management in terms of | a) VAS scores measured hourly for 48 hours. | b) Requirement of rescue analgesia | c) Cumulative dose of local anaesthetic at the end of 48 hours. a) VAS scores measured hourly for 48 hours. To compare the efficacy of PCEA and CEA in post op pain management in terms of | a) VAS scores measured hourly for 48 hours. | b) Requirement of rescue analgesia | c) Cumulative dose of local anaesthetic at the end of 48 hours. b) Requirement of rescue analgesia To compare the efficacy of PCEA and CEA in post op pain management in terms of | a) VAS scores measured hourly for 48 hours. | b) Requirement of rescue analgesia | c) Cumulative dose of local anaesthetic at the end of 48 hours. c) Cumulative dose of local anaesthetic at the end of 48 hours. To compare the efficacy of PCEA and CEA in post op pain management in terms of | a) VAS scores measured hourly for 48 hours. | b) Requirement of rescue analgesia | c) Cumulative dose of local anaesthetic at the end of 48 hours.
- Secondary Outcome Measures
Name Time Method a)To compare patient satisfaction in PCEA with CEA in the postoperative period b)To compare the incidence of side effects (Hypotension, Motor Weakness, Numbness. Nausea and Vomiting, Sedation, Pruritus, Respiratory depression, Postoperative ileus)
Trial Locations
- Locations (1)
St. Johns Medical College Hospital
🇮🇳Bangalore, KARNATAKA, India
St. Johns Medical College Hospital🇮🇳Bangalore, KARNATAKA, IndiaRosy JacobPrincipal investigator7829316825rosyjeevanjacob@gmail.com