Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607476362394 Date of Registration: 27/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ketamine, Lidocaine, and Placebo for Postoperative Pain After Laparoscopic Cholecystectomy
Official scientific title Perioperative Ketamine, Lidocaine, and Placebo for Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease and is among the most frequently performed abdominal procedures worldwide. Despite the minimally invasive nature of the technique, acute postoperative pain remains a major challenge during the first postoperative day.Current perioperative analgesic strategies increasingly rely on multimodal approaches targeting different nociceptive pathways involved in the generation and maintenance of postoperative pain. Perioperative intravenous lidocaine and low dose ketamine have demonstrated analgesic benefits in various surgical settings, but direct comparisons between these two pharmacological approaches remain scarce. Therefore, this study aimed to compare the effects of perioperative intravenous ketamine, lidocaine, and placebo on postoperative pain after elective laparoscopic cholecystectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 19/12/2024
Actual trial start date 19/12/2024
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date 30/06/2025
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
CEFMSo00312024
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lidocaine bolus of 1.5 mg/kg than a continued perfusion of 1.5 mg/kg/h maximum 120 minutes In the Lidocaïne group, immediately before tracheal intubation, patients received a 10 ml intravenous bolus lidocaine 1.5 mg kg−1. Than, before pneumoperitoneum insufflation, a continuous intravenous infusion was initiated and maintained until pneumoperitoneum release. Patients received lidocaine 1.5 mg kg−1 h−1, prepared in 20 ml syringes and administered at a fixed rate of 10 ml h−1. To maintain blinding and ensure standardized administration of the study drugs, the protocol was designed for procedures not exceeding 120 min in duration. 40
Experimental Group Ketamine bolus of ketamine 0.15mg/kg (serynge of 10ml) than a continued perfusion of ketamine 2.5µg/kg/min (serynge of 20ml) at a rate of 10ml/h maximum 120 minutes In the Ketamine group, immediately before tracheal intubation, patients received a 10 ml intravenous bolus containing ketamine 0.15 mg kg−1. than, before pneumoperitoneum insufflation, a continuous intravenous infusion was initiated and maintained until pneumoperitoneum release. Patients received ketamine 2.5 μg kg−1 min−1, prepared in 20 ml syringes and administered at a fixed rate of 10 ml h−1. To maintain blinding and ensure standardized administration of the study drugs, the protocol was designed for procedures not exceeding 120 min in duration. 40
Control Group Placebo Normal saline solution: 10 ml bolus than a continued perfusion of 20 ml at a rate of 10ml/h maximum of 120 minutes In the Placebo group, immediately before tracheal intubation, patients received a 10 ml intravenous bolus containing normal saline solution. Than, before pneumoperitoneum insufflation, a continuous intravenous infusion was initiated and maintained until pneumoperitoneum release. Patients received a continued perfusion of 20ml of normal saline solution at a rate of 10ml/h. To maintain blinding and ensure standardized administration of the study drugs, the protocol was designed for procedures not exceeding 120 min in duration. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Elective laparoscopic cholecystectomy for uncomplicated gallstone disease - Age ≥18 years - An American Society of Anesthesiologists (ASA) physical status of I–III - Patient provided written informed consent - History of chronic pain - Analgesic use within 24 h before surgery - Psychiatric disorders or antidepressant therapy - Inability to understand or use the visual analogue scale (VAS) - Body mass index >35 kg m−2 - Pregnancy or breastfeeding - Anticipated difficult airway requiring rapid-sequence induction - Acute cholecystitis - Contraindications to any study medication - Conversion to laparotomy was required - Postoperative abdominal drainage inserted - Major perioperative anaesthetic or surgical complications occurred during the first 24 postoperative hours - Postoperative admission to an intensive care unit. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/12/2024 Comite Ethique Medicale CEFMSo
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed KAROUI Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain intensity during the first 24 postoperative hours. Pain intensity was assessed using a 10-cm VAS at admission to the post-anaesthesia care unit (PACU) (E0) and at 6 h (E1), 12 h (E2), 18 h (E3), and 24 h (E4) after surgery E0: at admission to the post-anaesthesia care unit PACU, E1: at post operative 06 hours, E2 at post operative 12 hours, E3: at post operative 18 hours, E4: at 24 hours after surgery
Secondary Outcome Morphine consumption in the PACU, time to first rescue analgesic request, the proportion of patients requiring rescue analgesia, total intraoperative sufentanil consumption, sleep quality during the first postoperative night, and treatment-related adverse events. during the first 24 post operative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farhat HACHED University Teaching Hospital Avenue Ibn el JAZZAR Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Anaesthesia and intesive care unit Department at farhat HACHED University Teaching Hospital Avenue Ibn el JAZZAR Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anaesthesia and intensive care Department at Farhat HACHED University Teaching Hospital Avenue Ibn el JAZZAR Sousse 4000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hosni KHOUADJA hosni.khouadja@FAMSO.u-sousse.tn +21698403162 1, rue Ahmed KHAIREDDINE Khezama-Est
City Postal code Country Position/Affiliation
Sousse 4051 Tunisia Professor at anesthesia and intensive care Department Farhat HACHED University Hospital universite du centre
Role Name Email Phone Street address
Public Enquiries Mayssa MSALLEM maissa.msallem.mm@gmail.com +21658982909 1, rue Ahmed KHAIREDDINE Khezama-Est
City Postal code Country Position/Affiliation
Sousse 4051 Tunisia fellow ship in medecine at Anaesthesia and intensive care Department of Farhat HACHED University Teaching Hospital Universite du centre
Role Name Email Phone Street address
Scientific Enquiries Hosni KHOUADJA hosni.khouadja@FAMSO.u-sousse.tn +21698403162 1, rue Ahmed KHAIREDDINE Khezama-Est
City Postal code Country Position/Affiliation
Sousse 4051 Tunisia Professor at anesthesia and intensive care Department of Farhat HACHED University Hospital universite du centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual participant data (IPD) will be shared due to ethics committee restrictions and lack of explicit consent from participants. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Upon publication of the main results in a peer-reviewed journal. For a period of 3 years following publication. Methodological documents (protocol and blank consent form...) are available to academic researchers upon reasonable request to the Principal Investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 27/07/2026 PACTR Admin 19 Dec 2024