An interventional study of Bupivacaine and Standard Perioperative Analgesia in Postoperative Pain, sponsored by Allied Hospital Faisalabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Allied Hospital Faisalabad · Not applicable, Interventional, and Treatment
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
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 166 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Allied Hospital Faisalabad is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 18 to 60 years. Scheduled for elective laparoscopic abdominal surgery (e.g., cholecystectomy, appendectomy, or hernia repair).
(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 .
Exclusion Criteria:
Intraoperative conversion to open laparotomy. Known allergy, , or 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivacaine · Other: Standard Perioperative Analgesia
Participants undergoing elective laparoscopic abdominal surgery will receive standard perioperative care and postoperative analgesia without local bupivacaine infiltration at the trocar insertion sites.
Other: Standard Perioperative Analgesia
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 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.
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.
Time frame: At 1, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesia
Time elapsed from completion of surgery to the first administration of rescue opioid analgesia.
Time frame: 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.
Time frame: Within 24 hours after surgery
Plan to share: 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.
Start is estimated for Aug 2026; primary completion for Jan 2027, 5 months later.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 5 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine
Allied Hospital Faisalabad