Analgesic Efficacy of Free-opioid Anesthesia for Colorectal Surgery

NCT06042816 | Completed

• 1 other identifier: 01/CN-HDĐ
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship Hospital. Methods: A prospective, randomized controlled clinical trial was performed on 98 patients who were anesthetized for colorectal surgery from December 2019 to November 2021. Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.

Conditions

Colorectal Cancer

Keywords

Free-opioid anesthesia; Opioid anesthesia; colorectal surgery

Outcome Measures

Primary Outcomes (6)

• analgesic efficacy of free-opioid anesthesia

  intraoperative alteration of Surgical Pleth Index (SPI). The Surgical Pleth Index (SPI) is an objective tool that can reflect nociception-antinociception balance and guide the use of intraoperative analgesics. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended. When the SPI value is greater than 50 and exceeds 3-5 min, it routinely indicates that the noxious stimulation is too strong and that additional analgesic drugs are needed.

  before induction of anesthesia

• analgesic efficacy of free-opioid anesthesia

  intraoperative alteration of Surgical Pleth Index (SPI)

  After intubation

• analgesic efficacy of free-opioid anesthesia

  intraoperative alteration of Surgical Pleth Index (SPI)

  After skin incision

• analgesic efficacy of free-opioid anesthesia

  intraoperative alteration of Surgical Pleth Index (SPI)

  when the restoration of eyelids reflex emerged

• analgesic efficacy of free-opioid anesthesia

  The number of times of intraoperative analgesics adjustment

  Intraoperatively (From the induction of anesthesia to the emergence)

• analgesic efficacy of free-opioid anesthesia

  the proportion of patients requiring postoperative pain rescue

  postoperatively (upto 3 days after surgery)

Secondary Outcomes (39)

• Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

  T0 (right after entering the operating theatre)

• Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

  T1 (before induction of anesthesia)

• Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

  T2 (patients lost eyelid reflex and response to verbal command)

• Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

  T3 (before intubation)

• Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

  T4 (after intubation)

Study Arms (2)

Free-opioid anesthesia

EXPERIMENTAL

49 patients were injected bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg before induction. Then intravenous propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg were utilized for induction. For anesthesia maintenance, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI \> 50, 40 \< SE \< 60, TOF = 0 and hemodynamics was stable. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.

Procedure: Free-opioid anesthesia

Opioid anesthesia

ACTIVE COMPARATOR

49 patients received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia. For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) \> 50, 40 \< State Entropy (SE) \< 60, Train of four (TOF) = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.

Procedure: opioid anesthesia

Interventions

Free-opioid anesthesia PROCEDURE

Free opioid anesthesia (FOA) has been used in many countries around the world, making use of multimodal analgesia therapy which includes hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics and anti-inflammatory agents and sympathetic block in surgery. This method was demonstrated to contribute to enhanced recovery after surgery (ERAS). The use of long-acting local anesthetics also enhances postoperative pain relief. As a result, the concept of balanced anesthesia now has a change in three basic components: hypnotics, muscle relaxants and sympathomimetic inhibitors

Free-opioid anesthesia

opioid anesthesia PROCEDURE

Opioids have been used as one of three basic components of balanced anesthesia, including anesthetic drugs, pain relievers, and neuromuscular blockade agents (opioid anesthesia). Opioids not only facilitate deep anesthesia but also create the most favorable conditions for surgeries. Fentanyl is a potent opioid used to control pain, reduce the dose of sympathomimetic inhibitors and maintain hemodynamic stability. However, several common side effects of fentanyl are well known: nausea and vomiting, constipation, urinary retention, headache, pruritus, rash, histamine release, biliary spasm and respiratory depression, the most severe adverse effect

Opioid anesthesia

Eligibility Criteria

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

You may qualify if:

• Patients agreed to participate in the study.
• Patients aged ≥ 18 years old,
• Those who underwent elective colectomies or rectal resections,
• Those who were ASA (American Society of Anesthesiologists) classified as I - III,
• Those who were indicated for general endotracheal anesthesia from December 2019 to November 2021 at Viet Tiep Friendship Hospital

You may not qualify if:

• Patients refused to participate in the study,
• Patients had BMI (Body Mass Index) ≥ 35;
• Pregnant or lactating or menstruating women;
• Those who had liver failure, renal failure, heart failure, history of chronic pain, alcohol or drug abuse, mental illnesses, allergies or contraindications to any studied medications.
• Those who were unable to assess pain or use of patient-controlled analgesia devices (PCA).

Sponsors & Collaborators

• Vietnam Military Medical University: lead

Study Sites (1)

Viet-Tiep Friendship Hospital

Haiphong, Le Chan, 184570, Vietnam

Location

Related Publications (5)

• Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.

  PMID: 29207810 RESULT

• Choi H, Song JY, Oh EJ, Chae MS, Yu S, Moon YE. The Effect of Opioid-Free Anesthesia on the Quality of Recovery After Gynecological Laparoscopy: A Prospective Randomized Controlled Trial. J Pain Res. 2022 Aug 3;15:2197-2209. doi: 10.2147/JPR.S373412. eCollection 2022.

  PMID: 35945992 RESULT

• Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

  PMID: 25925031 RESULT

• Hakim KYK, Wahba WZB. Opioid-Free Total Intravenous Anesthesia Improves Postoperative Quality of Recovery after Ambulatory Gynecologic Laparoscopy. Anesth Essays Res. 2019 Apr-Jun;13(2):199-203. doi: 10.4103/aer.AER_74_19.

  PMID: 31198230 RESULT

• Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.

  PMID: 30180150 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kien T Nguyen, Ph.D

  Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103, Vietnam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The drugs were administered in 10 mL and 50 mL syringes labeled as ''loading'' or ''infusion'' respectively. All the drugs delivered in loading dose (intravenous lidocaine and ketamine, epidural levobupivacaine in FOA group; fentanyl and normal saline in OA group) were diluted in normal saline to 10 ml volume labeled indistinguishably as ''loading-1'' and ''loading-2'', "loading-3"…. Because the number of loading drugs in the FOA group was greater than in OA group, investigators added some 10 ml normal saline syringes in the OA group to make the number of "loading" syringes in the two groups equal, thereby ensuring complete blinding. The infusion drugs (lidocaine, ketamine and levobupivacaine in FOA group or normal saline in OA group) were prepared in 50 mL syringes and labeled as ''infusion-1'' and''infusion-2'' respectively. The patients and the anesthetists taking part in the procedures were not informed of the study protocol.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof, Nguyen Trung Kien, PhD, MD. Director of Center of Emergency, Critical Care Medicine and Clinical Toxicology, Military Hospital 103, Vietnam Military Medical University, Vietnam

Model Details: Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: December 30, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available when the publication is completed
• Access Criteria: The data is available only for research purposes and personal information of the participants need to be kept confidential

Locations

VN (1)