Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Randomised Controlled Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group L Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000 |
Drug: Lignocaine
Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000
Other Names:
|
| Placebo Comparator: Group P Intraperitoneal 20ml of 0.9% normal saline |
Drug: Normal Saline
Intraperitoneal 20ml of 0.9% normal saline
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain score [1-hour after surgery in the recovery bay]
At rest and movement
- Postoperative pain score [24-hour after surgery in the ward]
At rest and movement
- Postoperative pain score [48-hour after surgery in the ward]
At rest and movement
Secondary Outcome Measures
- Postoperative patient-controlled analgesia morphine consumption [24-hour after surgery in the ward]
Measured in milligrams
- Postoperative patient-controlled analgesia morphine consumption [48-hour after surgery in the ward]
Measured in milligrams
- Number of patients requiring rescue analgesia [Throughout in recovery bay after surgery, on average 2-hour after surgery]
Number of patients
- Postoperative nausea and vomiting [Throughout in the recovery bay after surgery, on average 2-hour after surgery]
Number of patients
- Adverse events of lignocaine [Throughout the study completion, on average of 48 hours]
Central nervous system or cardiovascular side effects- arrhythmias, dizziness or numbness
Eligibility Criteria
Criteria
Inclusion Criteria:
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all adult women (American Society of Anesthesiologists (ASA) who >18 years old and <60 years old
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gynaecological open surgery with midline or transverse laparotomy incision (below or above umbilicus)
Exclusion Criteria:
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laparoscopic surgery
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allergic to lignocaine
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history of cardiac, vascular or liver disease
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ASA 3-5 or
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body mass index <18/ or >40
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Malaya | Kuala Lumpur | Malaysia | 50603 |
Sponsors and Collaborators
- University of Malaya
Investigators
- Principal Investigator: Pui San Loh, MBBS, University of Malaya
- Principal Investigator: Ka Ting Ng, MBChB, University of Malaya
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.1