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Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Randomised Controlled Trial

Primary Purpose

Postoperative Pain, Gynecologic Disease, Local Anesthetic Systemic Toxicity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Lignocaine
Normal Saline
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Lignocaine, Postoperative pain, Analgesia, Surgery, Gynaecological

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: all adult women (American Society of Anesthesiologists (ASA) who >18 years old and <60 years old gynaecological open surgery with midline or transverse laparotomy incision (below or above umbilicus) Exclusion Criteria: laparoscopic surgery allergic to lignocaine history of cardiac, vascular or liver disease ASA 3-5 or body mass index <18/ or >40

Sites / Locations

  • University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group L

Group P

Arm Description

Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000

Intraperitoneal 20ml of 0.9% normal saline

Outcomes

Primary Outcome Measures

Postoperative pain score
At rest and movement
Postoperative pain score
At rest and movement
Postoperative pain score
At rest and movement

Secondary Outcome Measures

Postoperative patient-controlled analgesia morphine consumption
Measured in milligrams
Postoperative patient-controlled analgesia morphine consumption
Measured in milligrams
Number of patients requiring rescue analgesia
Number of patients
Postoperative nausea and vomiting
Number of patients
Adverse events of lignocaine
Central nervous system or cardiovascular side effects- arrhythmias, dizziness or numbness

Full Information

First Posted
May 21, 2023
Last Updated
May 31, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05897385
Brief Title
Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Randomised Controlled Trial
Official Title
Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Double-blinded Randomised Placebo-controlled Trial (IP LIGNO Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The incidence of postoperative pain is highly prevalent among surgical patients. Inadequate postoperative pain control can slow the recovery and it increases the risk of postoperative complications, namely lung collapse and chronic pain. Although morphine is the one of the gold standard analgesia option for postoperative pain, it comes with many unwanted adverse effects, such as severe nausea and vomiting, low blood pressure and dizziness. Thus, multimodal analgesia regime, including local anaesthetic (lignocaine) is strongly advocated for postoperative analgesia. The normal route of lignocaine is injected into vein for the properties of analgesia and anti-inflammatory. It exerts its effect via the systemic absorption of drugs to block the central neuronal pain transmission. In recent years, studies have demonstrated that instillation of lignocaine inside abdominal cavity can reduce internal organ pain by blocking free nerve ending inside abdomen with minimal systemic absorption of drug and lower complications of systemic toxicity of local anaesthesia as compared to the intravenous route of lignocaine. Several RCTs showed the beneficial effect of intraperitoneal lignocaine for the reduction of postoperative visceral pain after laparoscopic surgery. However, gynaecological open surgery (cystectomy, hysterectomy) involves greater degree of manipulation and trauma on the internal organs with greater visceral pain, resulting in longer duration of hospitalisation and delayed functional mobility recovery. It is believed that the intraperitoneal lignocaine reduces inflammatory response after surgery and exert analgesia effect by blocking the neural signal transmission at site of tissue injury. Therefore, it is important to conduct this study to examine the analgesic effect of intraperitoneal lignocaine in women undergoing gynaecological open surgery.
Detailed Description
Postoperative pain impedes the progress of recovery and increases the risk of postoperative complications, namely lung atelectasis, incidence of desaturation, pulmonary dysfunction and chronic pain. Although opioid is the one of the gold standard analgesia for postoperative pain, it comes with many unwanted adverse effects, such as respiratory depression, hypotension and incidence of nausea and vomiting. Thus, multimodal analgesia regime, including local anaesthetic is strongly advocated for postoperative analgesia. Lignocaine is a local anaesthetic agent, which has the properties of analgesia, anti-inflammatory and anti-arrhythmia effect via the blockade of sodium channel receptor in the spinal cord and dorsal root ganglia. The intravenous lignocaine exerts its effect via the systemic absorption of drugs to block the central neuronal transmission. In recent years, studies have demonstrated that intraperitoneal route of lignocaine can reduce visceral pain by inhibiting peritoneal free nerve ending and reduce peripheral neuronal hyper-excitatory of pain signal transmission. It is also believed that intraperitoneal lignocaine is associated with minimal systemic absorption of drug and lower incidence of systemic toxicity local anaesthesia as compared to the intravenous route of lignocaine. Several randomised controlled trials (RCTs) showed the beneficial effect of intraperitoneal lignocaine for the reduction of postoperative visceral pain after laparoscopic surgery. However, gynaecological open surgery has greater degree of organ manipulation and tissue injury with greater visceral pain, resulting in longer duration of hospitalisation and delayed functional mobility recovery. It is believed that the intraperitoneal lignocaine reduces inflammatory response after surgery and exert analgesia effect by blocking the neural pain signal transmission at site of tissue injury. The dosage of intraperitoneal lignocaine used in the literature ranged from 200-400mg. The serum concentration of intraperitoneal lignocaine was measured, which was associated with a relatively safe serum concentration of lignocaine. Pharmacological studies have showed that the adjuvant dose of adrenaline reduced the systematic absorption of intraperitoneal lignocaine. Therefore, this study is designed to examine the analgesic effect of intraperitoneal lignocaine in gynaecological open surgery. We hypothesised that intraperitoneal lignocaine reduces postoperative pain score at rest and movement in women undergoing gynaecological open surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Gynecologic Disease, Local Anesthetic Systemic Toxicity
Keywords
Lignocaine, Postoperative pain, Analgesia, Surgery, Gynaecological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Active Comparator
Arm Description
Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Intraperitoneal 20ml of 0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Lignocaine
Other Intervention Name(s)
INJECSOL LIG2
Intervention Description
Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
B. Braun 0.9% Sodium Chloride Inj. B.P
Intervention Description
Intraperitoneal 20ml of 0.9% normal saline
Primary Outcome Measure Information:
Title
Postoperative pain score
Description
At rest and movement
Time Frame
1-hour after surgery in the recovery bay
Title
Postoperative pain score
Description
At rest and movement
Time Frame
24-hour after surgery in the ward
Title
Postoperative pain score
Description
At rest and movement
Time Frame
48-hour after surgery in the ward
Secondary Outcome Measure Information:
Title
Postoperative patient-controlled analgesia morphine consumption
Description
Measured in milligrams
Time Frame
24-hour after surgery in the ward
Title
Postoperative patient-controlled analgesia morphine consumption
Description
Measured in milligrams
Time Frame
48-hour after surgery in the ward
Title
Number of patients requiring rescue analgesia
Description
Number of patients
Time Frame
Throughout in recovery bay after surgery, on average 2-hour after surgery
Title
Postoperative nausea and vomiting
Description
Number of patients
Time Frame
Throughout in the recovery bay after surgery, on average 2-hour after surgery
Title
Adverse events of lignocaine
Description
Central nervous system or cardiovascular side effects- arrhythmias, dizziness or numbness
Time Frame
Throughout the study completion, on average of 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all adult women (American Society of Anesthesiologists (ASA) who >18 years old and <60 years old gynaecological open surgery with midline or transverse laparotomy incision (below or above umbilicus) Exclusion Criteria: laparoscopic surgery allergic to lignocaine history of cardiac, vascular or liver disease ASA 3-5 or body mass index <18/ or >40
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Ting Ng, MBChB
Phone
+60379492411
Email
katingng1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pui San Loh, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ka Ting Ng, MBChB
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Ting Ng, MBChB
Phone
+60379492042
First Name & Middle Initial & Last Name & Degree
Ka Ting Ng, MBChB
First Name & Middle Initial & Last Name & Degree
Pui San Loh, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24758776
Citation
Perniola A, Magnuson A, Axelsson K, Gupta A. Intraperitoneal local anesthetics have predominant local analgesic effect: a randomized, double-blind study. Anesthesiology. 2014 Aug;121(2):352-61. doi: 10.1097/ALN.0000000000000267.
Results Reference
result
PubMed Identifier
9215018
Citation
Williamson KM, Cotton BR, Smith G. Intraperitoneal lignocaine for pain relief after total abdominal hysterectomy. Br J Anaesth. 1997 Jun;78(6):675-7. doi: 10.1093/bja/78.6.675.
Results Reference
result
PubMed Identifier
27984226
Citation
Patel R, Carvalho JC, Downey K, Kanczuk M, Bernstein P, Siddiqui N. Intraperitoneal Instillation of Lidocaine Improves Postoperative Analgesia at Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2017 Feb;124(2):554-559. doi: 10.1213/ANE.0000000000001799.
Results Reference
result
PubMed Identifier
10714840
Citation
Elhakim M, Elkott M, Ali NM, Tahoun HM. Intraperitoneal lidocaine for postoperative pain after laparoscopy. Acta Anaesthesiol Scand. 2000 Mar;44(3):280-4. doi: 10.1034/j.1399-6576.2000.440310.x.
Results Reference
result
PubMed Identifier
8130042
Citation
Rademaker BM, Kalkman CJ, Odoom JA, de Wit L, Ringers J. Intraperitoneal local anaesthetics after laparoscopic cholecystectomy: effects on postoperative pain, metabolic responses and lung function. Br J Anaesth. 1994 Mar;72(3):263-6. doi: 10.1093/bja/72.3.263.
Results Reference
result
PubMed Identifier
20090438
Citation
Shahin AY, Osman AM. Intraperitoneal lidocaine instillation and postcesarean pain after parietal peritoneal closure: a randomized double blind placebo-controlled trial. Clin J Pain. 2010 Feb;26(2):121-7. doi: 10.1097/AJP.0b013e3181b99ddd.
Results Reference
result

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Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Randomised Controlled Trial

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