Effects of TIVA With Propofol Versus Inhalational Anaesthesia on Postoperative Pain After Hepatectomy

NCT03597997 | Completed Phase 4

• 1 other identifier: UW18-176
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Propofol is a commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, and better wake up profile. But the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are potential disadvantages of TIVA propofol. Results from clinical trials have not been consistent. Some randomized trials have shown improved analgesia with TIVA propofol, and some reported no significant difference. A meta-analysis found that propofol was associated with a statistically significant reduction pain scores 24 hours after surgery. However, the clinical effect size was small. Therefore, the usefulness of propofol as an analgesic adjunct is still inconclusive. Whether TIVA propofol is useful in providing significant postoperative analgesia may be influenced by the type of surgery and accompanying analgesic regime. This agrees with the concept of procedure specific analgesia. Liver surgery produces moderate to severe pain as a result of an upper abdominal incision. Pain control can be difficult due to concerns with epidural analgesia in patients with potential clotting abnormalities and the effect of analgesic metabolism as a in patients with liver dysfunction. Results from our retrospective study showed that TIVA propofol was associated with reduced pain scores with coughing on postoperative days 1 and 2, and also reduced opioid consumption when compared with sevoflurane after liver surgery. In this study, the investigators plan to conduct a randomized controlled trial to further determine whether TIVA propofol reduces acute postoperative pain and opioid consumption after hepatectomy.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Total intravenous anaesthesia; TIVA; Propofol; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Pain assessed by numercial rating scales (NRS) pain scores

  NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded at rest and with coughing everyday.

  at postoperative day 1

Secondary Outcomes (3)

• PCA morphin consumption

  from postoperative day 0 until postoperative day 5

• Dihydrocodeine use

  from postoperative day 0 until postoperative day 5

• Side effects of analgesics

  from postoperative day 0 until postoperative day 5

Study Arms (2)

Group P

EXPERIMENTAL

The patients in group (P) will be anaesthetized using total intravenous propofol.

Drug: Propofol

Group S

SHAM COMPARATOR

Patients in group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane.

Drug: Sevoflurane

Interventions

Propofol DRUG

Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Monitoring and other anaesthetic procedures including the management of hypertension and hypotension in group P will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Oxygen and air would be given to provide a FiO2 of 30-50%.

Group P

Sevoflurane DRUG

Propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously for induction of general anaesthesia. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to maintain a BIS value of between 40-60. Intravenous remifentanil infusion between 0.1-0.2 mcg/kg/min will be given and this will be titrated to provide optimal haemodynamic parameters.

Group S

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to III
• Scheduled for elective hepatectomy (left or right hepatectomy, segmentectomy, or wedge resection)

You may not qualify if:

• Known drug allergy to propofol, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol, ketamine
• Alcohol or drug abuse
• Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
• Impaired or retarded mental state
• BMI \> 35kg/m2
• History of chronic pain
• Pregnancy
• Local infection
• History of psychosis, delirium
• Chronic opioid user
• Patient refusal

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Wong SSC, Wang F, Chan TCW, Cheung CW. The analgesic effect of total intravenous anaesthesia with propofol versus inhalational anaesthesia for acute postoperative pain after hepatectomy: a randomized controlled trial. BMC Anesthesiol. 2023 Apr 3;23(1):112. doi: 10.1186/s12871-023-02063-7.

  PMID: 37013472 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Stanley SC Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will not be aware of the type of anaesthesia they will receive. A separate blinded investigator will assess the patients after the operation. The anaesthetist providing general anaesthesia will be aware of the allocation, but s/he will not be involved in data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients in one group (S) will be anaesthetized by inhalational anaesthesia using sevoflurane. The patients in the second group (P) will be anaesthetized using total intravenous propofol.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 24, 2018
• Study Start: August 27, 2018
• Primary Completion: July 15, 2021
• Study Completion: December 1, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

HK (2)