Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery

NCT05897385 | Completed DMC

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Gynecologic Disease; Local Anesthetic Systemic Toxicity

Keywords

Lignocaine; Postoperative pain; Analgesia; Surgery; Gynaecological

Outcome Measures

Primary Outcomes (3)

• Postoperative pain score

  At rest and movement (0- no pain, 10- most pain)

  1-hour after surgery in the recovery bay

• Postoperative pain score

  At rest and movement (0- no pain, 10- most pain)

  24-hour after surgery in the ward

• Postoperative pain score

  At rest and movement (0- no pain, 10- most pain)

  48-hour after surgery in the ward

Secondary Outcomes (5)

• Postoperative patient-controlled analgesia morphine consumption

  24-hour after surgery in the ward

• Postoperative patient-controlled analgesia morphine consumption

  48-hour after surgery in the ward

• Number of patients requiring rescue analgesia

  Throughout in recovery bay after surgery, on average 2-hour after surgery

• Postoperative nausea and vomiting

  Throughout in the recovery bay after surgery, on average 2-hour after surgery

• Adverse events of lignocaine

  Throughout the study completion, on average of 48 hours

Study Arms (2)

Group L

ACTIVE COMPARATOR

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

Drug: Lignocaine

Group P

PLACEBO COMPARATOR

Intraperitoneal 20ml of 0.9% normal saline

Drug: Normal Saline

Interventions

Lignocaine DRUG

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

Also known as: INJECSOL LIG2

Group L

Normal Saline DRUG

Intraperitoneal 20ml of 0.9% normal saline

Also known as: B. Braun 0.9% Sodium Chloride Inj. B.P

Group P

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• laparoscopic surgery
• allergic to lignocaine
• history of cardiac, vascular or liver disease
• ASA 3-5 or
• body mass index \<18/ or \>40

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (6)

• 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.

  PMID: 24758776 RESULT

• 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.

  PMID: 9215018 RESULT

• 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.

  PMID: 27984226 RESULT

• 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.

  PMID: 10714840 RESULT

• 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.

  PMID: 8130042 RESULT

• 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.

  PMID: 20090438 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Genital Diseases, Female; Agnosia

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pui San Loh, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Ka Ting Ng, MBChB

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 9, 2023
• Study Start: August 22, 2023
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)