Postoperative PainNCT07747584
Effect of Local Anesthetic Infiltration for Postoperative Pain Control in Laparoscopic Abdominal Surgery: A Prospective Randomized Study
A study testing Bupivacaine and Standard Perioperative Analgesia in people with Postoperative Pain, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
Brief Summary Postoperative pain remains a common problem after laparoscopic abdominal surgery despite the minimally invasive nature of these procedures. Pain mainly arises from the trocar insertion sites, tissue manipulation, and the effects of pneumoperitoneum. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine and Standard Perioperative Analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2026to Jan 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years. Scheduled for elective laparoscopic abdominal surgery (e.g., cholecystectomy, appendectomy, or hernia repair).
- American Society of Anesthesiologists (ASA) physical status I or II. Able to understand and use the Visual Analog Scale (VAS) for pain assessment. Willing and able to provide written informed consent.
Who cannot join
- Intraoperative conversion to open laparotomy. Known allergy, hypersensitivity, or contraindication to bupivacaine or other amide local anesthetics.
- Pregnancy or breastfeeding. History of chronic pain syndromes or regular use of opioid or non-opioid analgesics before surgery.
- History of substance abuse or severe psychiatric disorders that may affect pain perception.
- Local skin infection at the planned trocar insertion sites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allied Hospital Faisalabad
Faisalābad, Punjab Province, 38000
Jawad Qamar, MBBS, 00923060403567, jawadqamar22@gmail.com
About this study
Brief Summary
Postoperative pain remains a common problem after laparoscopic abdominal surgery despite the minimally invasive nature of these procedures. Pain mainly arises from the trocar insertion sites, tissue manipulation, and the effects of pneumoperitoneum. Although systemic analgesics are routinely used, they may not provide adequate pain relief and can be associated with adverse effects.
Read more
This prospective randomized controlled trial aims to evaluate whether pre-incisional infiltration of bupivacaine at laparoscopic trocar insertion sites reduces postoperative pain compared with standard care without local anesthetic infiltration. A total of 166 adult patients undergoing elective laparoscopic abdominal surgery will be randomly assigned to receive either local bupivacaine infiltration before skin incision or no local anesthetic infiltration. All participants will receive the same standard perioperative care and postoperative analgesic regimen.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include the time to first rescue analgesic, total opioid consumption within the first 24 hours, and overall postoperative pain control. The results of this study may help determine whether local bupivacaine infiltration is an effective, simple, and low-cost addition to multimodal analgesia for patients undergoing laparoscopic abdominal surgery.
Read the detailed description
Detailed Description
Laparoscopic abdominal surgery is widely performed because it is associated with reduced surgical trauma, shorter hospital stays, and faster recovery compared with open procedures. Despite these advantages, postoperative pain remains a significant concern. Pain after laparoscopy is multifactorial, resulting from trocar insertion, tissue manipulation, and pneumoperitoneum. Although multimodal analgesia is routinely employed, optimal management of trocar-site pain remains uncertain.
Local infiltration of surgical incision sites with long-acting local anesthetics such as bupivacaine has been proposed as a simple and inexpensive method of reducing postoperative pain and opioid requirements. However, published randomized trials have reported inconsistent findings regarding the magnitude of benefit, and variations in infiltration technique, timing, and dosage have limited the establishment of standardized recommendations. Additional prospective randomized studies are needed to evaluate the effectiveness of this intervention in different clinical settings.
This single-center prospective randomized controlled trial will be conducted in the Department of General Surgery, Allied Hospital, Faisalabad. Adult patients undergoing elective laparoscopic abdominal surgery will be randomly allocated in a 1:1 ratio to receive either pre-incisional infiltration of diluted bupivacaine at planned trocar insertion sites or no local anesthetic infiltration. All participants will receive the institution's standard perioperative management and postoperative analgesic protocol.
The study aims to determine whether pre-incisional local bupivacaine infiltration provides superior postoperative pain control during the first 24 hours after laparoscopic abdominal surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS), while opioid consumption and time to first rescue analgesia will be evaluated as secondary measures of analgesic efficacy. The findings may help clarify the role of local anesthetic infiltration as part of multimodal postoperative pain management and contribute evidence to guide clinical practice in patients undergoing laparoscopic abdominal surgery.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Standard Perioperative Analgesia
- Keywords
- Postoperative Pain, Laparoscopic Surgery, Laparoscopic Abdominal Surgery, Bupivacaine, Local Anesthetic Infiltration, Trocar Site Infiltration, Multimodal Analgesia, Visual Analog Scale, Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivacaine 0.5% (5 mg/mL), 20 mL diluted with 20 mL of normal saline to achieve a final concentration of 0.25% (40 mL total volume). The solution will be infiltrated equally into the planned laparoscopic trocar insertion sites before skin incision.
Standard Perioperative AnalgesiaOther
Standard perioperative analgesia according to the institutional protocol, including intravenous paracetamol 1 g every 8 hours and intravenous tramadol 50 mg administered as rescue analgesia for patients with a Visual Analog Scale (VAS) pain score ≥4 during the first 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Infiltration Plus Standard Care | Experimental | Participants undergoing elective laparoscopic abdominal surgery will receive pre-incisional infiltration of 20 mL of 0.5% bupivacaine diluted with 20 mL of normal saline (final concentration 0.25%). The solution will be equally infiltrated into the planned trocar insertion sites before skin incision in addition to standard perioperative care. Receives: Drug: Bupivacaine; Other: Standard Perioperative Analgesia |
| Standard Care | Active comparator | Participants undergoing elective laparoscopic abdominal surgery will receive standard perioperative care and postoperative analgesia without local bupivacaine infiltration at the trocar insertion sites. Receives: Other: Standard Perioperative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity measured using the Visual Analog Scale (VAS; 0-10), comparing the experimental and control groups during the first 24 hours after laparoscopic abdominal surgery.
Measured: At 1, 6, 12, and 24 hours after surgery
Secondary outcomes (2)
Time to First Rescue Analgesia
Time elapsed from completion of surgery to the first administration of rescue opioid analgesia.
Measured: Within 24 hours after surgery
Total Opioid Consumption
Total cumulative opioid dose administered as rescue analgesia during the first 24 hours after laparoscopic abdominal surgery.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive pre-incisional infiltration of diluted bupivacaine at the planned laparoscopic trocar insertion sites before skin incision, while the control group will undergo the same laparoscopic procedure without local anesthetic infiltration. Outcomes will be compared between the two groups during the first 24 hours after surgery.
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jawad Qamar, Allied Hospital Faisalabad
- Investigators
- Muhammad Akram, MBBS, FCPS General Surgery, Study chair, Department of General Surgery, Allied Hospital, Faisalabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747584
- Sponsor's protocol ID
- 48ERC/FMU/2025-26/300
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center, investigator-initiated academic study. The study protocol does not include provisions for public sharing of de-identified participant-level data, and data sharing has not been approved by the sponsoring institution or ethics committee.
Publications
Nakngam N, Wasinghon P, Ratanakaew A. Bupivacaine Local Infiltration at Trocar Insertion Sites after Gynecologic Laparoscopic Surgery: A Randomized, Double-blind, Placebo-Controlled Trial. Journal of the Medical Association of Thailand. 2024;107(3):185-190. DOI: 10.35755/jmedassocthai.2024.3.13955
Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.
PubMed 33420214Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.
PubMed 15572499
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthetic Infiltration for Postoperative Pain Control in Laparoscopic Abdominal Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07747584
- Acronym / sponsor ID
- 48ERC/FMU/2025-26/300
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Laparoscopic Surgery, Laparoscopic Abdominal Surgery, Bupivacaine, Local Anesthetic Infiltration, Trocar Site Infiltration, Multimodal Analgesia, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Aug 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.
Brief Summary
Postoperative pain remains a common problem after laparoscopic abdominal surgery despite the minimally invasive nature of these procedures. Pain mainly arises from the trocar insertion sites, tissue manipulation, and the effects of pneumoperitoneum. Although systemic analgesics are routinely used, they may not provide adequate pain relief and can be associated with adverse effects.
This prospective randomized controlled trial aims to evaluate whether pre-incisional infiltration of bupivacaine at laparoscopic trocar insertion sites reduces postoperative pain compared with standard care without local anesthetic infiltration. A total of 166 adult patients undergoing elective laparoscopic abdominal surgery will be randomly assigned to receive either local bupivacaine infiltration before skin incision or no local anesthetic infiltration. All participants will receive the same standard perioperative care and postoperative analgesic regimen.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include the time to first rescue analgesic, total opioid consumption within the first 24 hours, and overall postoperative pain control. The results of this study may help determine whether local bupivacaine infiltration is an effective, simple, and low-cost addition to multimodal analgesia for patients undergoing laparoscopic abdominal surgery.
Detailed description
Detailed Description
Laparoscopic abdominal surgery is widely performed because it is associated with reduced surgical trauma, shorter hospital stays, and faster recovery compared with open procedures. Despite these advantages, postoperative pain remains a significant concern. Pain after laparoscopy is multifactorial, resulting from trocar insertion, tissue manipulation, and pneumoperitoneum. Although multimodal analgesia is routinely employed, optimal management of trocar-site pain remains uncertain.
Local infiltration of surgical incision sites with long-acting local anesthetics such as bupivacaine has been proposed as a simple and inexpensive method of reducing postoperative pain and opioid requirements. However, published randomized trials have reported inconsistent findings regarding the magnitude of benefit, and variations in infiltration technique, timing, and dosage have limited the establishment of standardized recommendations. Additional prospective randomized studies are needed to evaluate the effectiveness of this intervention in different clinical settings.
This single-center prospective randomized controlled trial will be conducted in the Department of General Surgery, Allied Hospital, Faisalabad. Adult patients undergoing elective laparoscopic abdominal surgery will be randomly allocated in a 1:1 ratio to receive either pre-incisional infiltration of diluted bupivacaine at planned trocar insertion sites or no local anesthetic infiltration. All participants will receive the institution's standard perioperative management and postoperative analgesic protocol.
The study aims to determine whether pre-incisional local bupivacaine infiltration provides superior postoperative pain control during the first 24 hours after laparoscopic abdominal surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS), while opioid consumption and time to first rescue analgesia will be evaluated as secondary measures of analgesic efficacy. The findings may help clarify the role of local anesthetic infiltration as part of multimodal postoperative pain management and contribute evidence to guide clinical practice in patients undergoing laparoscopic abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive pre-incisional infiltration of diluted bupivacaine at the planned laparoscopic trocar insertion sites before skin incision, while the control group will undergo the same laparoscopic procedure without local anesthetic infiltration. Outcomes will be compared between the two groups during the first 24 hours after surgery.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Infiltration Plus Standard Care | Experimental | Drug: Bupivacaine, Other: Standard Perioperative AnalgesiaParticipants undergoing elective laparoscopic abdominal surgery will receive pre-incisional infiltration of 20 mL of 0.5% bupivacaine diluted with 20 mL of normal saline (final concentration 0.25%). The solution will be equally infiltrated into the planned trocar insertion sites before skin incision in addition to standard perioperative care. |
| Standard Care | Active comparator | Other: Standard Perioperative AnalgesiaParticipants undergoing elective laparoscopic abdominal surgery will receive standard perioperative care and postoperative analgesia without local bupivacaine infiltration at the trocar insertion sites. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 60 years. Scheduled for elective laparoscopic abdominal surgery (e.g., cholecystectomy, appendectomy, or hernia repair).
- American Society of Anesthesiologists (ASA) physical status I or II. Able to understand and use the Visual Analog Scale (VAS) for pain assessment. Willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Intraoperative conversion to open laparotomy. Known allergy, hypersensitivity, or contraindication to bupivacaine or other amide local anesthetics.
- Pregnancy or breastfeeding. History of chronic pain syndromes or regular use of opioid or non-opioid analgesics before surgery.
- History of substance abuse or severe psychiatric disorders that may affect pain perception.
- Local skin infection at the planned trocar insertion sites.
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 |
|---|---|---|
| BupivacaineBupivacaine 0.5% (5 mg/mL), 20 mL diluted with 20 mL of normal saline to achieve a final concentration of 0.25% (40 mL total volume). The solution will be infiltrated equally into the planned laparoscopic trocar insertion sites before skin incision. | Drug | Bupivacaine Infiltration Plus Standard Care |
| Standard Perioperative AnalgesiaStandard perioperative analgesia according to the institutional protocol, including intravenous paracetamol 1 g every 8 hours and intravenous tramadol 50 mg administered as rescue analgesia for patients with a Visual Analog Scale (VAS) pain score ≥4 during the first 24 hours after surgery. | Other | Bupivacaine Infiltration Plus Standard Care, Standard Care |
Primary outcome
Postoperative Pain Intensity
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative pain intensity measured using the Visual Analog Scale (VAS; 0-10), comparing the experimental and control groups during the first 24 hours after laparoscopic abdominal surgery.
2 secondary outcomes
Time to First Rescue Analgesia
Time frame: Within 24 hours after surgery
Total Opioid Consumption
Time frame: Within 24 hours 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 5 Aug 2026.
- BackgroundNakngam N, Wasinghon P, Ratanakaew A. Bupivacaine Local Infiltration at Trocar Insertion Sites after Gynecologic Laparoscopic Surgery: A Randomized, Double-blind, Placebo-Controlled Trial. Journal of the Medical Association of Thailand. 2024;107(3):185-190. DOI: 10.35755/jmedassocthai.2024.3.13955
- Background: PubMed 33420214Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.
- Background: PubMed 15572499Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center, investigator-initiated academic study. The study protocol does not include provisions for public sharing of de-identified participant-level data, and data sharing has not been approved by the sponsoring institution or ethics committee.
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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.
Muhammad Akram, MBBS, FCPS General Surgery study chair
Department of General Surgery, Allied Hospital, Faisalabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Standard Perioperative Analgesia in people with Postoperative Pain, run by Allied Hospital Faisalabad at 1 site in Pakistan.
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 4 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 5 Aug 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 Pakistan. 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 Jawad Qamar, MBBS (+923060403567, jawadqamar22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: At 1, 6, 12, and 24 hours after surgery). 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 NCT07747584, which also lists 3 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 5 Aug 2026.