Laparoscopic Gynecological SurgeryNCT07322029
Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Gynecological Surgery
A study testing Intrathecal morphine group, TAPB and Intrathecal saline injection in people with Laparoscopic Gynecological Surgery, run by Sun Yat-sen University at 1 site in China.
Trial summary
Minimally invasive gynecologic surgery has become the standard approach for the treatment of benign and malignant gynecologic diseases, offering the advantages of reduced surgical trauma and faster recovery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgery
- What is being tested?
- Intrathecal morphine group, TAPB and Intrathecal saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years.
- Scheduled for elective laparoscopic gynecological surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to provide written informed consent.
Who cannot join
- Contraindications to neuraxial anesthesia.
- Allergy to morphine or local anesthetics.
- Long-term opioid use (>20 morphine milligram equivalents per day).
- Baseline NRS pain score >3.
- Cognitive impairment or inability to cooperate.
- Emergency or non-elective surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-Sen University Cancer Center
Guangdong, Guangzhou
Renchun Lai, MD, +8613660012343, lairch@sysucc.org.cn
About this study
Minimally invasive gynecologic surgery has become the standard approach for the treatment of benign and malignant gynecologic diseases, offering the advantages of reduced surgical trauma and faster recovery. However, postoperative pain remains a major barrier to optimal recovery, with up to 40% of patients experiencing moderate to severe pain within the first 24 hours after laparoscopic procedures. Laparoscopic gynecologic surgery typically induces both somatic pain from abdominal wall incisions and visceral pain caused by peritoneal traction and pneumoperitoneum, making effective analgesia challenging. Transversus abdominis plane block (TAPB) is commonly used to control somatic incisional pain but provides limited relief of visceral pain, often resulting in increased opioid consumption and opioid-related adverse effects such as dizziness and postoperative nausea and vomiting. Intrathecal morphine (ITM) offers potent and long-lasting visceral analgesia with minimal systemic opioid requirements and has demonstrated safety and efficacy across multiple surgical settings. The complementary analgesic mechanisms of TAPB and intrathecal morphine suggest that their combination may enhance postoperative recovery by improving pain control while reducing opioid use.
The objective of this randomized controlled trial is to evaluate whether the combination of intrathecal morphine and TAPB improves the quality of recovery after laparoscopic gynecologic surgery compared with TAPB alone. This study aims to provide high-quality clinical evidence to guide the development of an optimized multimodal analgesia strategy for patients undergoing minimally invasive gynecologic procedures.
Read the detailed description
All patients will receive standardized general anesthesia combined with bilateral transversus abdominis plane block. The intervention group will additionally receive intrathecal morphine, whereas the control group will receive intrathecal saline. After entering the operating room, routine monitoring will include electrocardiography, pulse oximetry, noninvasive blood pressure, heart rate, and end-tidal carbon dioxide. Prior to anesthesia induction, patients in the intervention group will undergo lumbar intrathecal injection of morphine at the L3/4 or L4/5 or L5/S1 interspace. Based on previous literature and clinical experience, intrathecal morphine will be administered at a dose of 2 ug/kg. The control group will receive an equivalent volume of intrathecal normal saline under identical conditions.
General anesthesia will be induced with intravenous dexmedetomidine (0.5 ug/kg), Propofol (1.5-2 mg/kg), remifentanil (TCI 4 ng/mL), and rocuronium (0.6 mg/kg), followed by endotracheal intubation. Bilateral TAPB will be performed in all patients under ultrasound guidance. A total of 60 mL of diluted bupivacaine liposome (20 mL: 266 mg diluted to 60 mL with normal saline) will be administered, with 15 mL injected at each of the bilateral subcostal and lateral approaches (total 60 mL). Anesthesia maintenance will include 1.0-1.3 MAC desflurane, remifentanil, sufentanil, rocuronium, and vasoactive medications as required. Intraoperative opioid consumption will be recorded.
Postoperative analgesia will be provided using intravenous patient-controlled analgesia (PCA), consisting of 100 mg morphine diluted to a total volume of 100 mL. The PCA settings will include no background dose, a 1-mL bolus dose, and a 6-minute lockout interval. In cases of adverse events such as hypotension, fluid resuscitation and vasoactive support will be provided, and PCA parameters may be reduced or discontinued by an independent nurse if necessary.
The primary outcome of this study is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. Secondary outcomes include postoperative pain scores, opioid consumption, postoperative nausea and vomiting, pruritus, and other opioid-related adverse events. This trial aims to evaluate whether the combination of intrathecal morphine and TAPB provides superior analgesia and improves recovery after gynecologic laparoscopic surgery.
- Conditions
- Laparoscopic Gynecological Surgery
- Being tested
- Intrathecal morphine group, TAPB, Intrathecal saline injection
- Keywords
- laparoscopic gynecological surgery, QoR-15, Intrathecal morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine groupProcedure or surgery
With the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and intrathecal morphine was injected following confirmation of free cerebrospinal fluid flow.
TAPBProcedure or surgery
With the patient supine, a linear ultrasound probe was placed between the costal margin and iliac crest to identify the abdominal wall layers. Using an in-plane approach, a needle was advanced into the transversus abdominis plane, and after negative aspiration, liposomal bupivacaine was injected under direct ultrasound visualization. The block was performed bilaterally.
Intrathecal saline injectionProcedure or surgery
With the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and an equal volume of preservative-free normal saline was injected after confirming cerebrospinal fluid flow.
TAPBProcedure or surgery
With the patient supine, a linear ultrasound probe was placed between the costal margin and iliac crest to identify the abdominal wall layers. Using an in-plane approach, a needle was advanced into the transversus abdominis plane, and after negative aspiration, liposomal bupivacaine was injected under direct ultrasound visualization. The block was performed bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine group | Experimental | Before anesthesia induction, patients in the intervention group received an intrathecal injection of morphine at the L3-4 or L4-5 or L5-S1 interspace. The intrathecal morphine dose was 2 μg/kg. Receives: Procedure: Intrathecal morphine group; Procedure: TAPB |
| Normal saline group | Active comparator | Before anesthesia induction, patients in the control group received an intrathecal injection of an equal volume of preservative-free normal saline at the L3-4 or L4-5 or L5-S1 interspace. Receives: Procedure: Intrathecal saline injection; Procedure: TAPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15 score at 24 hours after surgery
The Quality of Recovery-15 questionnaire is a validated patient-reported outcome measure assessing postoperative recovery across five domains (pain, physical comfort, emotional state, physical independence, and psychological support). Total scores range from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 24 hours after surgery
Secondary outcomes (14)
QoR-15 score at 48 and 72 hours postoperatively
The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 48 and 72 hours after surgery
Numeric Rating Scale (NRS) pain score at rest and cough at 24, 48, and 72 hours postoperatively
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: 24, 48, and 72 hours after surgery
Rest and cough NRS scores in post-anesthesia care unit (PACU) after surgery
Pain intensity will be assessed using the NRS, ranging from 0 to 10, with higher scores indicating greater pain intensity
Measured: 30 minutes after surgery
Cumulative morphine equivalent consumption at 24, 48, and 72 hours postoperatively
Measured: 24, 48, and 72 hours after surgery
Time to first postoperative flatus
Measured: Up to 1 week after surgery
Time to first ambulation after surgery
Time from surgery to the first postoperative ambulation.
Measured: Up to 1 week after surgery
Urinary catheter indwelling time
Time from surgery to urinary catheter removal.
Measured: Up to 1 week after surgery
Time to first analgesic request
Measured: Up to 72 hours after surgery
Total amount of additional analgesic medication at 24, 48, 72 hours postoperatively
Measured: 24, 48, and 72 hours after surgery
Patient satisfaction assessed by a 0-100 numeric scale
Patient satisfaction with postoperative analgesia will be assessed using a numeric rating scale ranging from 0 to 100, where 0 indicates the lowest level of satisfaction and 100 indicates the highest level of satisfaction.
Measured: At 72 hours after surgery
Length of hospital stay (days)
Length of hospital stay is defined as the number of days from surgery to hospital discharge.
Measured: From surgery to hospital discharge
Incidence of postoperative shoulder pain assessed by the NRS
Postoperative shoulder pain will be assessed by patient report, defined as the presence of shoulder pain with a NRS score ≥1 during the postoperative period.
Measured: Up to 72 hours after surgery
Incidence of adverse events at 24, 48, and 72 hours postoperatively
Postoperative adverse events include hypotension, dizziness, pruritus, and postoperative nausea and vomiting, assessed by clinical observation and medical records.
Measured: 24, 48, and 72 hours after surgery
Incidence of chronic pain at 3 months and 6 months after surgery
Measured: 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Gynecological SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RenChun Lai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322029
- Sponsor's protocol ID
- 2025-FXY-311
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT07322029
- Acronym / sponsor ID
- 2025-FXY-311
- Conditions
- Laparoscopic Gynecological Surgery
- Keywords
- laparoscopic gynecological surgery, QoR-15, Intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
Minimally invasive gynecologic surgery has become the standard approach for the treatment of benign and malignant gynecologic diseases, offering the advantages of reduced surgical trauma and faster recovery. However, postoperative pain remains a major barrier to optimal recovery, with up to 40% of patients experiencing moderate to severe pain within the first 24 hours after laparoscopic procedures. Laparoscopic gynecologic surgery typically induces both somatic pain from abdominal wall incisions and visceral pain caused by peritoneal traction and pneumoperitoneum, making effective analgesia challenging. Transversus abdominis plane block (TAPB) is commonly used to control somatic incisional pain but provides limited relief of visceral pain, often resulting in increased opioid consumption and opioid-related adverse effects such as dizziness and postoperative nausea and vomiting. Intrathecal morphine (ITM) offers potent and long-lasting visceral analgesia with minimal systemic opioid requirements and has demonstrated safety and efficacy across multiple surgical settings. The complementary analgesic mechanisms of TAPB and intrathecal morphine suggest that their combination may enhance postoperative recovery by improving pain control while reducing opioid use.
The objective of this randomized controlled trial is to evaluate whether the combination of intrathecal morphine and TAPB improves the quality of recovery after laparoscopic gynecologic surgery compared with TAPB alone. This study aims to provide high-quality clinical evidence to guide the development of an optimized multimodal analgesia strategy for patients undergoing minimally invasive gynecologic procedures.
Detailed description
All patients will receive standardized general anesthesia combined with bilateral transversus abdominis plane block. The intervention group will additionally receive intrathecal morphine, whereas the control group will receive intrathecal saline. After entering the operating room, routine monitoring will include electrocardiography, pulse oximetry, noninvasive blood pressure, heart rate, and end-tidal carbon dioxide. Prior to anesthesia induction, patients in the intervention group will undergo lumbar intrathecal injection of morphine at the L3/4 or L4/5 or L5/S1 interspace. Based on previous literature and clinical experience, intrathecal morphine will be administered at a dose of 2 ug/kg. The control group will receive an equivalent volume of intrathecal normal saline under identical conditions.
General anesthesia will be induced with intravenous dexmedetomidine (0.5 ug/kg), Propofol (1.5-2 mg/kg), remifentanil (TCI 4 ng/mL), and rocuronium (0.6 mg/kg), followed by endotracheal intubation. Bilateral TAPB will be performed in all patients under ultrasound guidance. A total of 60 mL of diluted bupivacaine liposome (20 mL: 266 mg diluted to 60 mL with normal saline) will be administered, with 15 mL injected at each of the bilateral subcostal and lateral approaches (total 60 mL). Anesthesia maintenance will include 1.0-1.3 MAC desflurane, remifentanil, sufentanil, rocuronium, and vasoactive medications as required. Intraoperative opioid consumption will be recorded.
Postoperative analgesia will be provided using intravenous patient-controlled analgesia (PCA), consisting of 100 mg morphine diluted to a total volume of 100 mL. The PCA settings will include no background dose, a 1-mL bolus dose, and a 6-minute lockout interval. In cases of adverse events such as hypotension, fluid resuscitation and vasoactive support will be provided, and PCA parameters may be reduced or discontinued by an independent nurse if necessary.
The primary outcome of this study is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. Secondary outcomes include postoperative pain scores, opioid consumption, postoperative nausea and vomiting, pruritus, and other opioid-related adverse events. This trial aims to evaluate whether the combination of intrathecal morphine and TAPB provides superior analgesia and improves recovery after gynecologic laparoscopic 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 |
|---|---|---|
| Intrathecal morphine group | Experimental | Procedure: Intrathecal morphine group, Procedure: TAPBBefore anesthesia induction, patients in the intervention group received an intrathecal injection of morphine at the L3-4 or L4-5 or L5-S1 interspace. The intrathecal morphine dose was 2 μg/kg. |
| Normal saline group | Active comparator | Procedure: Intrathecal saline injection, Procedure: TAPBBefore anesthesia induction, patients in the control group received an intrathecal injection of an equal volume of preservative-free normal saline at the L3-4 or L4-5 or L5-S1 interspace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged ≥18 years.
- Scheduled for elective laparoscopic gynecological surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Contraindications to neuraxial anesthesia.
- Allergy to morphine or local anesthetics.
- Long-term opioid use (>20 morphine milligram equivalents per day).
- Baseline NRS pain score >3.
- Cognitive impairment or inability to cooperate.
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 |
|---|---|---|
| Intrathecal morphine groupWith the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and intrathecal morphine was injected following confirmation of free cerebrospinal fluid flow. | Procedure or surgery | Intrathecal morphine group |
| TAPBWith the patient supine, a linear ultrasound probe was placed between the costal margin and iliac crest to identify the abdominal wall layers. Using an in-plane approach, a needle was advanced into the transversus abdominis plane, and after negative aspiration, liposomal bupivacaine was injected under direct ultrasound visualization. The block was performed bilaterally. | Procedure or surgery | Intrathecal morphine group |
| Intrathecal saline injectionWith the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and an equal volume of preservative-free normal saline was injected after confirming cerebrospinal fluid flow. | Procedure or surgery | Normal saline group |
| TAPBWith the patient supine, a linear ultrasound probe was placed between the costal margin and iliac crest to identify the abdominal wall layers. Using an in-plane approach, a needle was advanced into the transversus abdominis plane, and after negative aspiration, liposomal bupivacaine was injected under direct ultrasound visualization. The block was performed bilaterally. | Procedure or surgery | Normal saline group |
Primary outcome
QoR-15 score at 24 hours after surgery
Time frame: 24 hours after surgery
The Quality of Recovery-15 questionnaire is a validated patient-reported outcome measure assessing postoperative recovery across five domains (pain, physical comfort, emotional state, physical independence, and psychological support). Total scores range from 0 to 150, with higher scores indicating better quality of recovery.
14 secondary outcomes
QoR-15 score at 48 and 72 hours postoperatively
Time frame: 48 and 72 hours after surgery
Numeric Rating Scale (NRS) pain score at rest and cough at 24, 48, and 72 hours postoperatively
Time frame: 24, 48, and 72 hours after surgery
Rest and cough NRS scores in post-anesthesia care unit (PACU) after surgery
Time frame: 30 minutes after surgery
Cumulative morphine equivalent consumption at 24, 48, and 72 hours postoperatively
Time frame: 24, 48, and 72 hours after surgery
Time to first postoperative flatus
Time frame: Up to 1 week after surgery
Time to first ambulation after surgery
Time frame: Up to 1 week after surgery
Urinary catheter indwelling time
Time frame: Up to 1 week after surgery
Time to first analgesic request
Time frame: Up to 72 hours after surgery
Total amount of additional analgesic medication at 24, 48, 72 hours postoperatively
Time frame: 24, 48, and 72 hours after surgery
Patient satisfaction assessed by a 0-100 numeric scale
Time frame: At 72 hours after surgery
Length of hospital stay (days)
Time frame: From surgery to hospital discharge
Incidence of postoperative shoulder pain assessed by the NRS
Time frame: Up to 72 hours after surgery
Incidence of adverse events at 24, 48, and 72 hours postoperatively
Time frame: 24, 48, and 72 hours after surgery
Incidence of chronic pain at 3 months and 6 months after surgery
Time frame: 3 months and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine group, TAPB and Intrathecal saline injection in people with Laparoscopic Gynecological Surgery, run by Sun Yat-sen University at 1 site in China.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renchun Lai, MD (+8613660012343, lairch@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 score at 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.