Comparison of patient controlled epidural analgesia (PCEA) with continuous epidural analgesia (CEA) for postoperative pain management after major abdominal oncologic surgeries :A Prospective Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- St Johns Medical College
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of PCEA and CEA in post op pain management in terms of
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 59.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To compare the efficacy of PCEA and CEA in post op pain management in terms of
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Time Frame: 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 Outcomes
- 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))