Postoperative PainNCT05897385
Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery
A study testing Lignocaine and Normal Saline in people with Postoperative Pain and Gynecologic Disease, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Gynecologic Disease, Local Anesthetic Systemic Toxicity
- What is being tested?
- Lignocaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Aug 2023to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- laparoscopic surgery
- allergic to lignocaine
- history of cardiac, vascular or liver disease
- ASA 3-5 or
- body mass index <18/ or >40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Double-blinded Randomised Placebo-controlled Trial (IP LIGNO Trial)
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.
Read the 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. The investigators hypothesised that intraperitoneal lignocaine reduces postoperative pain score at rest and movement in women undergoing gynaecological open surgery.
- Being tested
- Lignocaine, Normal Saline
- Keywords
- Lignocaine, Postoperative pain, Analgesia, Surgery, Gynaecological
- Medical subject headings
- Pain, Postoperative, Genital Diseases, Female, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
Also called INJECSOL LIG2
Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000
Normal SalineDrug
Also called B. Braun 0.9% Sodium Chloride Inj. B.P
Intraperitoneal 20ml of 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000 Receives: Drug: Lignocaine |
| Group P | Placebo comparator | Intraperitoneal 20ml of 0.9% normal saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
At rest and movement (0- no pain, 10- most pain)
Measured: 1-hour after surgery in the recovery bay
Postoperative pain score
At rest and movement (0- no pain, 10- most pain)
Measured: 24-hour after surgery in the ward
Postoperative pain score
At rest and movement (0- no pain, 10- most pain)
Measured: 48-hour after surgery in the ward
Secondary outcomes (5)
Postoperative patient-controlled analgesia morphine consumption
Measured in milligrams
Measured: 24-hour after surgery in the ward
Postoperative patient-controlled analgesia morphine consumption
Measured in milligrams
Measured: 48-hour after surgery in the ward
Number of patients requiring rescue analgesia
Number of patients
Measured: Throughout in recovery bay after surgery, on average 2-hour after surgery
Postoperative nausea and vomiting
Number of patients
Measured: Throughout in the recovery bay after surgery, on average 2-hour after surgery
Adverse events of lignocaine
Central nervous system or cardiovascular side effects- arrhythmias, dizziness or numbness
Measured: Throughout the study completion, on average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start22 Aug 2023
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pui San Loh, MBBS, Principal investigator, University of MalayaKa Ting Ng, MBChB, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897385
- Sponsor's protocol ID
- 1.1
- Status last verified
- Jan 2026
- First submitted
- 21 May 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24758776Williamson 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.
PubMed 9215018Patel 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.
PubMed 27984226Elhakim 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.
PubMed 10714840Rademaker 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.
PubMed 8130042Shahin 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.
PubMed 20090438
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery: A Double-blinded Randomised Placebo-controlled Trial (IP LIGNO Trial)
- ClinicalTrials.gov ID
- NCT05897385
- Acronym / sponsor ID
- 1.1
- Keywords
- Lignocaine, Postoperative pain, Analgesia, Surgery, Gynaecological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators hypothesised that intraperitoneal lignocaine reduces postoperative pain score at rest and movement in women undergoing gynaecological open surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: LignocaineIntraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000 |
| Group P | Placebo comparator | Drug: Normal SalineIntraperitoneal 20ml of 0.9% normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- laparoscopic surgery
- allergic to lignocaine
- history of cardiac, vascular or liver disease
- ASA 3-5 or
- body mass index <18/ or >40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LignocaineAlso: INJECSOL LIG2Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000 | Drug | Group L |
| Normal SalineAlso: B. Braun 0.9% Sodium Chloride Inj. B.PIntraperitoneal 20ml of 0.9% normal saline | Drug | Group P |
Primary outcome
Postoperative pain score
Time frame: 1-hour after surgery in the recovery bay
At rest and movement (0- no pain, 10- most pain)
Postoperative pain score
Time frame: 24-hour after surgery in the ward
At rest and movement (0- no pain, 10- most pain)
Postoperative pain score
Time frame: 48-hour after surgery in the ward
At rest and movement (0- no pain, 10- most pain)
5 secondary outcomes
Postoperative patient-controlled analgesia morphine consumption
Time frame: 24-hour after surgery in the ward
Postoperative patient-controlled analgesia morphine consumption
Time frame: 48-hour after surgery in the ward
Number of patients requiring rescue analgesia
Time frame: Throughout in recovery bay after surgery, on average 2-hour after surgery
Postoperative nausea and vomiting
Time frame: Throughout in the recovery bay after surgery, on average 2-hour after surgery
Adverse events of lignocaine
Time frame: Throughout the study completion, on average of 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 24758776Perniola 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 publication: PubMed 9215018Williamson 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 publication: PubMed 27984226Patel 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 publication: PubMed 10714840Elhakim 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 publication: PubMed 8130042Rademaker 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 publication: PubMed 20090438Shahin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pui San Loh, MBBS principal investigator
University of Malaya
Ka Ting Ng, MBChB principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine and Normal Saline in people with Postoperative Pain and Gynecologic Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 1-hour after surgery in the recovery bay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897385, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.