Spinal Morphine and Atropine Added to General Anaesthesia for Nausea and Pain After Abdominal Laparoscopy

NCT07851870 | Completed Phase 4 DMC

• 1 other identifier: 2106795356
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic abdominal surgery carries one of the highest risks of postoperative nausea and vomiting (PONV), and postoperative opioids given for pain are themselves emetogenic. Intrathecal morphine provides prolonged analgesia but increases nausea; intrathecal atropine 100 µg has been reported to reduce morphine-related nausea under spinal anaesthesia alone, but has not been tested within a combined spinal-general technique. This randomised, open-label, parallel-group trial compared combined spinal-general anaesthesia (CSGA), hyperbaric bupivacaine 10 mg, morphine 100 µg and atropine 100 µg given intrathecally before induction, followed by general anaesthesia, with general anaesthesia (GA) alone in adults undergoing elective abdominal laparoscopy. Both groups received identical general anaesthesia, multimodal analgesia (paracetamol and ketorolac at skin closure), end-of-case ondansetron and neostigmine-atropine reversal. The primary outcome was the occurrence of PONV within 24 hours after surgery. Secondary outcomes were postoperative pain, rescue antiemetic and rescue opioid requirements, intraoperative fentanyl consumption and perioperative haemodynamics.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Anesthesia; Anesthesia Spinal; Laparoscopy

Keywords

Atropine; Intrathecal; Morphine; Spinal anaesthesia; PONV; Laparoscopy; Opioid sparing

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting (PONV)

  Proportion of participants with a score of 1 or more on a 5-point PONV analogue visual scale (0 = none; 1 = nausea \<10 min or one vomit, no treatment; 2 = nausea \>10 min or two vomits, no treatment; 3 = nausea \>10 min or more than two vomits requiring treatment; 4 = refractory to treatment), assessed at 1 h in recovery and at 2, 6, 12 and 24 h on the ward. Higher scores indicate worse outcome.

  Within 24 hours after surgery

Secondary Outcomes (8)

• Postoperative pain intensity

  2, 6, 12 and 24 hours after surgery

• Number of participants requiring rescue morphine

  Within 24 hours

• Number of participants requiring rescue ondansetron

  Within 24 hours

• Total post-induction fentanyl dose

  Intraoperative period, from induction to end of anaesthesia

• Mean arterial pressure

  Pre-induction, after spinal injection, at and after insufflation, after desufflation, after extubation (intraoperative period)

Study Arms (2)

Combined spinal-general anaesthesia (CSGA)

EXPERIMENTAL

Before induction, spinal anaesthesia at L4-5 in the sitting position with a 27-G Quincke needle: 0.5% hyperbaric bupivacaine 10 mg, preservative-free morphine 100 µg and atropine sulphate 100 µg, made up to 4 mL with 0.9% saline, targeting a T6 sensory level. General anaesthesia was then induced and maintained as in the comparator arm.

Drug: Intrathecal bupivacaine, morphine and atropine; Procedure: General anaesthesia; Drug: Multimodal analgesia and antiemetic prophylaxis

GA alone

ACTIVE COMPARATOR

General anaesthesia without any neuraxial block: induction with lidocaine 1.5 mg/kg, fentanyl 2 µg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg; maintenance with sevoflurane in oxygen-air at target MAC 0.8, with fentanyl 25-50 µg boluses for haemodynamic response.

Procedure: General anaesthesia; Drug: Multimodal analgesia and antiemetic prophylaxis

Interventions

Intrathecal bupivacaine, morphine and atropine DRUG

Hyperbaric bupivacaine 10 mg + preservative-free morphine 100 µg + atropine sulphate 100 µg in 4 mL, single intrathecal injection before induction

Combined spinal-general anaesthesia (CSGA)

General anaesthesia PROCEDURE

Lidocaine, fentanyl, propofol, rocuronium induction; sevoflurane maintenance; neostigmine-atropine reversal

Combined spinal-general anaesthesia (CSGA); GA alone

Multimodal analgesia and antiemetic prophylaxis DRUG

Paracetamol 1 g and ketorolac 30 mg IV at skin closure; ondansetron 4 mg IV at end of anaesthesia

Combined spinal-general anaesthesia (CSGA); GA alone

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 64 years
• ASA physical status I or II
• Body mass index 30 kg/m² or less
• Scheduled for elective digestive, gynaecological or urological laparoscopy
• Written informed consent given

You may not qualify if:

• Uncontrolled stage 2 hypertension
• Heart failure, arrhythmia, valvular heart disease or atrioventricular block
• Cerebrovascular event within the previous 3 months
• Raised intracranial pressure
• Severe renal or hepatic disease
• Coagulopathy
• Infection at the site of lumbar puncture

Sponsors & Collaborators

• Universitas Indonesia: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (1)

Cipto Mangunkusumo National Central General Hospital (RSCM)

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Morphine; Atropine; Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Anesthesia; Anesthesia and Analgesia

Study Officials

• Pryambodho Pryambodho, MD

  Department of Anesthesiology and Intensive Care, FKUI-RSCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-group parallel-assignment design. Eligible adults undergoing elective abdominal laparoscopy were allocated in a 1:1 ratio to combined spinal-general anaesthesia or general anaesthesia alone, using a random sequence generated by a research assistant with www.randomizer.org. No allocation concealment or masking was used; the allocation sequence was known to the investigators throughout. Consent was obtained by a researcher not involved in the participant's clinical care. Each participant received one allocated technique only, with no crossover.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 1, 2026
• Study Start: February 2, 2026
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)